This paper comprehensively explores the technical principles and application practice of Sainaoning absorbable dural sealant medical adhesive in dural closure.It elaborates on the research and development background o...This paper comprehensively explores the technical principles and application practice of Sainaoning absorbable dural sealant medical adhesive in dural closure.It elaborates on the research and development background of Sainaoning,analyzes its composition,action mechanism,and product characteristics in detail,and presents the results of pre-clinical and clinical studies.The application of Sainaoning in different craniotomy surgeries is discussed,and its effectiveness and safety are evaluated.The paper also analyzes the challenges in its application and proposes corresponding countermeasures,aiming to provide a comprehensive understanding and reference for the clinical use and further development of Sainaoning.展开更多
AIM: To report a systematic review of published randomized controlled trials(RCTs) investigating the role of absorbable suture(AS) against non-AS(NAS) used for the closure of surgical incisions.METHODS: RCTs investiga...AIM: To report a systematic review of published randomized controlled trials(RCTs) investigating the role of absorbable suture(AS) against non-AS(NAS) used for the closure of surgical incisions.METHODS: RCTs investigating the use of AS vs NAS for the closure of surgical incisions were statistically analysed based upon the principles of meta-analysis and the summated outcomes were represented as OR.RESULTS: The systematic search of medical literature yielded 10 RCTs on 1354 patients. Prevalence of wound infection(OR = 0.97; 95%CI: 0.56, 1.69; Z = 0.11; P = 0.92) and operative morbidity(P = 0.45) was comparable in both groups. Nonetheless, the use of AS lead to lower risk of wound break-down(OR = 0.12; 95%CI: 0.04, 0.39; Z = 3.52; P 【 0.0004).CONCLUSION: This meta-analysis of 10 RCTs demonstrates that the use of AS is similar to NAS for skin closure for surgical site infection and other operative morbidities. AS do not increase the risk of skin wound dehiscence,rather lead to a reduced risk of wound dehiscence compared to NAS.展开更多
Paraesophageal hernia(PEH)repair is one of the most challenging upper gastrointestinal operations.Its high rate of recurrence is due mostly to the low quality of the crura and size of the hiatal defect.In an attempt t...Paraesophageal hernia(PEH)repair is one of the most challenging upper gastrointestinal operations.Its high rate of recurrence is due mostly to the low quality of the crura and size of the hiatal defect.In an attempt to diminish the recurrence rates,some clinical investigators have begun performing meshreinforced cruroplasty with nonabsorbable meshes like polypropylene or polytetrafluoroethylene.The main problem with these materials is the occurrence,in some patients,of serious mesh-related morbidities,such as erosions into the stomach and the esophagus,some of which necessitate subsequent esophagectomy or gastrectomy.Absorbable meshes can be synthetic or biological and were introduced in recent years for PEH repair with the intent of diminishing the recurrence rates observed after primary repair alone but,theoretically,without the risks of morbidities presented by the nonabsorbable meshes.The current role of absorbable meshes in PEH repair is still under debate,since there are few data regarding their long-term efficacy,particularly in terms of recurrence rates,morbidity,need for revision,and quality of life.In this opinion review,we analyze all the presently available evidence of reinforced cruroplasty for PEH repair using nonabsorbable meshes(synthetic or biological),focusing particularly on recurrence rates,mesh-related morbidity,and long-term quality of life.展开更多
In order to improve the success rate of chronic total occlusion (CTO)percutaneous coronary intervention (PCI), retrograde approach has been attracted more attention.Recent study reported the collateral perforation rat...In order to improve the success rate of chronic total occlusion (CTO)percutaneous coronary intervention (PCI), retrograde approach has been attracted more attention.Recent study reported the collateral perforation rate was 6.9% in retrograde CTO PCI.[1,2] Collateral related perforations were higher in patients with the epicardial collateral than that with the septal collateral.[3]Several techniques have been developed to deal with the collateral branch perforation.Here,we described the treatment of epicardial collateral branch perforation by absorbable suture segments embolization through microcatheter during retrograde CTO PCI.展开更多
AIM:To investigate the biomechanical properties and practical application of absorbable materials in orbital fracture repair.METHODS:The three-dimensional(3D)model of orbital blowout fractures was reconstructed using ...AIM:To investigate the biomechanical properties and practical application of absorbable materials in orbital fracture repair.METHODS:The three-dimensional(3D)model of orbital blowout fractures was reconstructed using Mimics21.0 software.The repair guide plate model for inferior orbital wall fracture was designed using 3-matic13.0 and Geomagic wrap 21.0 software.The finite element model of orbital blowout fracture and absorbable repair plate was established using 3-matic13.0 and ANSYS Workbench 21.0 software.The mechanical response of absorbable plates,with thicknesses of 0.6 and 1.2 mm,was modeled after their placement in the orbit.Two patients with inferior orbital wall fractures volunteered to receive single-layer and double-layer absorbable plates combined with 3D printing technology to facilitate surgical treatment of orbital wall fractures.RESULTS:The finite element models of orbital blowout fracture and absorbable plate were successfully established.Finite element analysis(FEA)showed that when the Young’s modulus of the absorbable plate decreases to 3.15 MPa,the repair material with a thickness of 0.6 mm was influenced by the gravitational forces of the orbital contents,resulting in a maximum total deformation of approximately 3.3 mm.Conversely,when the absorbable plate was 1.2 mm thick,the overall maximum total deformation was around 0.4 mm.The half-year follow-up results of the clinical cases confirmed that the absorbable plate with a thickness of 1.2 mm had smaller maximum total deformation and better clinical efficacy.CONCLUSION:The biomechanical analysis observations in this study are largely consistent with the clinical situation.The use of double-layer absorbable plates in conjunction with 3D printing technology is recommended to support surgical treatment of infraorbital wall blowout fractures.展开更多
To develop a new generation of absorbable fracture fixation devices with enhanced biocompatibility, the biodegradation mechanism and its influence on the cellular response at the tissue/implant interface of hydroxyapa...To develop a new generation of absorbable fracture fixation devices with enhanced biocompatibility, the biodegradation mechanism and its influence on the cellular response at the tissue/implant interface of hydroxyapatite/ poly DL lactide (HA/PDLLA) composites were investigated in vitro and in vivo.HA/PDLLA rods were immersed in phosphate buffered saline,or implanted in muscle and bony tissue for 52 weeks.Scanning electron microscopic and histological studies were done.The degradation rate was the slowest in vitro,slower in muscle tissue and fast in bone.In vitro, the composites degraded heterogeneously and a hollow structure was formed.In bone,the limited clearing capacity leads to the accumulation of oligomeric debris,which contribute totally to the autocatalytic effect.So,the fastest degradation and intense tissue response were seen.In muscle tissue,oligomeric debris migrated into vicinal fibers over a long distance from the original implant cavity and the tissue reactions were,however, quite moderate.For the same size organic/inorganic composite,the environment where it was placed is the major factor in determining its biodegradation process and cellular reaction.In living tissue,factors such as cells,enzymes and mechanical stress have an obvious influence on the biodegradation and biological process at the tissue/implant interface.The biocompatibility of the HA/PDLLA composites is enhanced with the incorporating of the resorbable HA microparticles.展开更多
This paper reviewed all types of the polymer - based synthetic absorbable surgical sutures that have been commercially produced. The chemical component, biological and mechanical properties, and using effect of these ...This paper reviewed all types of the polymer - based synthetic absorbable surgical sutures that have been commercially produced. The chemical component, biological and mechanical properties, and using effect of these sutures were discussed. The recent development and the possible coming research orientation in these areas were also presented.展开更多
Objective:To study the effects of absorbable materials in non-weight-bearing bone fractures of extremities.Methods:After 66 patients with nonweight-bearing bone fractures of extremities were selected,absorbable materi...Objective:To study the effects of absorbable materials in non-weight-bearing bone fractures of extremities.Methods:After 66 patients with nonweight-bearing bone fractures of extremities were selected,absorbable materials were used in the observation group and metal materials were used in the control group.Results:After treatment,the bone healing in the observation group was significantly improved(P<0.05).Conclusion:the application of absorbable materials in non-weight-bearing bone fractures of extremities is effective.展开更多
Objective:To study the trauma and bone metabolism after internal absorbable screw and metal screw fixation treatment of tibia-fibula fracture. Methods:78 patients with tibia-fibula fracture who received internal fixat...Objective:To study the trauma and bone metabolism after internal absorbable screw and metal screw fixation treatment of tibia-fibula fracture. Methods:78 patients with tibia-fibula fracture who received internal fixation surgery in our hospital between May 2013 and October 2015 were selected and randomly divided into absorbable group and metal group (n=39) who accepted internal absorbable screw fixation and internal metal screw fixation respectively. 3 d after operation, serum was collected to determine the levels of inflammatory factors, pain mediators, stress hormones and bone metabolism indexes. Results: Serum inflammatory mediators procalcitonin (PCT), Resistin, C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α(TNF-α), pain mediators substance P (SP), prostaglandin E2 (PGE2) and NPY, stress hormones norepinephrine (NE), epinephrine (E) and cortisol (Cor) as well as bone resorption marker molecules C-terminal telopeptides of type I collagen (CTX-I) and C-terminal telopeptides of type II collagen (CTX-II) levels of absorbable group were significantly lower than those of metal group (P<0.05) while bone formation marker molecules N-MID osteocalcin (N-MID) and N-terminal propeptide of procollagen type I (PINP) levels were significantly higher than those of metal group (P<0.05). Conclusions:The trauma degree of internal absorbable screw fixation treatment of tibia-fibula fracture is weaker than that of internal metal screw fixation, and the bone metabolism activity is better than that of internal metal screw fixation.展开更多
Objective To observe the degradability of absorbable sutures in tendon grafts and the histology of tendon healing in a rabbit model.Methods Semitendinosus tendons were harvested from 15 healthy adult New Zealand rabbi...Objective To observe the degradability of absorbable sutures in tendon grafts and the histology of tendon healing in a rabbit model.Methods Semitendinosus tendons were harvested from 15 healthy adult New Zealand rabbits in this study.展开更多
Magnesium alloys present a compelling prospect for absorbable implant materials in orthopedic and trauma surgery.This study evaluates an ultra-high purity,lean magnesium-calcium alloy(X0),both with and without plasma ...Magnesium alloys present a compelling prospect for absorbable implant materials in orthopedic and trauma surgery.This study evaluates an ultra-high purity,lean magnesium-calcium alloy(X0),both with and without plasma electrolytic oxidation(PEO)surface modification,in comparison to a clinically utilized WE43 magnesium alloy.It is shown that the mechanical properties of X0 can be tuned to yield a high-strength material suitable for bone screws(with an ultimate tensile strength of 336 MPa)or a ductile material appropriate for intraoperatively deformable plates(with an elongation at fracture of 24%).Four plate-screw combinations were implanted onto the pelvic bones of six sheep without osteotomy for 8 weeks.Subsequent analysis utilized histology,micro-computed tomography,and light and electron microscopy.All implants exhibited signs of degradation and hydrogen-gas evolution,with PEO-coated X0 implants demonstrating the least volume loss and the most sub-stantial new-bone formation on the implant surface and surrounding cancellous bone.Furthermore,the osteo-conductive properties of the X0 implants,when uncoated,exceeded those of the uncoated WE43 implants,as evidenced by greater new-bone formation on the surface.This osteoconductivity was amplified with PEO surface modification,which mitigated gas evolution and enhanced osseointegration,encouraging bone apposition in the cancellous bone vicinity.These findings thus indicate that PEO-coated X0 implants hold substantial promise as a biocompatible and absorbable implant material.展开更多
Background Absorbable cranial flap fixation products,represented by Aesculap^(®)CranioFix absorbable clamp,are widely used in neurosurgery.However,the product has some shortcomings,as it is not entirely biodegrad...Background Absorbable cranial flap fixation products,represented by Aesculap^(®)CranioFix absorbable clamp,are widely used in neurosurgery.However,the product has some shortcomings,as it is not entirely biodegradable,the lower disc’s angle cannot be adjusted,and there is a failure to readjust after fixation.To address these issues,MedArt Technology Co.,Ltd.from China has come up with a high-purity PLLA combined with an innovative structural design to develop a novel cranial flap fixation system that is more convenient to operate,has a better resetting effect,and can be fully absorbed.This study aims to verify its safety and effectiveness through in vitro experiments and clinical trials.Methods In this study,the absorbable cranial flap fixation system of MedArt was used as the experimental group,and the CranioFix absorbable clamp constituted the control group.The material properties and the changing trend of mechanical properties of the two groups were compared by accelerated degradation experiments in vitro.A multicenter,randomized,parallel,positive-controlled,non-inferiority clinical study was conducted with a 48-week follow-up.The shortening degree of the bone flap gap,qualified rate of bone flap displacement,changing trend of implant volume,and occurrence of postoperative adverse events were compared between the two groups.Results The results of the in vitro accelerated degradation showed that in terms of the decrease in intrinsic viscosity,the control and experimental groups took 7 days and 14 days,respectively,to reach the test endpoint.For mechanical properties,the control group and experimental groups lost clinical safety fixation significance on the 3rd and 4th day after the degradation began,respectively.Regarding the release of degradation products,the control group showed a burst of lactic acid release during the first 3-7 days,while the experimental group released lactic acid slowly and constantly.In the clinical study,90 patients were randomly enrolled,87 of whom completed the operation,with an average age of 50.The 3D reconstruction of CT images showed that the bone flap gaps in both groups were less than 2 mm after surgery.The qualified rate of bone flap displacement in the experimental group was 100%after surgery.In contrast,in the control group,there was one unqualified case at 1 week after surgery and two unqualified cases at 6 weeks,12 weeks,24 weeks,and 48 weeks.The residual volume of the implant in the experimental group was closer to 50%(about 48.8%)48 weeks after surgery,than in the control group(about 43.9%)12 weeks after surgery.Regarding safety,only one possible device-related adverse event occurred in the control group,with an incidence rate of 2.22%,manifested as poor healing at the incision site.Conclusions The study has verified that the experimental group had better stability,longer biodegradation time,and better mechanical properties than the control group.Moreover,the experimental group could significantly narrow the cranial flap gap,reduce the flap displacement,and promote skull healing after craniotomy.It shows a fairly reliable fixation effect and safety.展开更多
Over the past two decades,advances in arthroscopic and minimally invasive surgical techniques have led to significant growth in sports medicine surgery.Implants such as suture anchors,interference screws,and endo-butt...Over the past two decades,advances in arthroscopic and minimally invasive surgical techniques have led to significant growth in sports medicine surgery.Implants such as suture anchors,interference screws,and endo-buttons are commonly used in these procedures.However,traditional implants made of metal or inert materials are not absorbable,leading to complications that affect treatment outcomes.To address this issue,absorbable materials with excellent mechanical properties,good biocompatibility,and controlled degradation rates have been developed and applied in clinical practice.These materials include absorbable polymers,absorbable bioceramics,and absorbable metals.In this paper,we will provide a comprehensive summary of these absorbable materials from the perspective of clinicians,and discuss their clinical applications and related research in sport medicine.展开更多
The locking plate and percutaneous crossing metallic screws and crossing absorbable screws have been used clinically to treat intra-articular calcaneal fractures, but little is known about the biomechanical difference...The locking plate and percutaneous crossing metallic screws and crossing absorbable screws have been used clinically to treat intra-articular calcaneal fractures, but little is known about the biomechanical differences between them. This study compared the biomechanical stability of calcaneal fractures fixed using a locking plate and crossing screws. Three-dimensional finite-element models of intact and fractured calcanei were developed based on the CT images of a cadaveric sample. Surgeries were simulated on models of Sanders type III calcaneal fractures to produce accurate postoperative models fixed by the three implants. A vertical force was applied to the superior surface of the subtalar joint to simulate the stance phase of a walking gait. This model was validated by an in vitro experiment using the same calcaneal sample. The intact calcaneus showed greater stiffness than the fixation models. Of the three fixations, the locking plate produced the greatest stiffness and the highest von Mises stress peak. The micromotion of the fracture fixated with the locking plate was similar to that of the fracture fixated with the metallic screws but smaller than that fixated with the absorbable screws. Fixation with both plate and crossing screws can be used to treat intra-articular calcaneal fractures. In general, fixation with crossing metallic screws is preferable because it provides sufficient stability with less stress shielding.展开更多
Background The primary objective of this multicenter post-market study was to compare the cosmetic outcome of triclosan-coated VICRYL＊ Plus sutures with Chinese silk sutures for skin closure of modified radical maste...Background The primary objective of this multicenter post-market study was to compare the cosmetic outcome of triclosan-coated VICRYL＊ Plus sutures with Chinese silk sutures for skin closure of modified radical mastectomy. A secondary objective was to assess the incidence of surgical site infection （SSI）.Methods Patients undergoing modified radical mastectomy were randomly assigned to coated VICRYL＊ Plus antibacterial （Polyglactin 910） suture or Chinese silk suture. Cosmetic outcomes were evaluated postoperatively at days 12 （±2） and 30 （±5）, and the evidence of SSI was assessed at days 3, 5, 7, 12 （±2）, 30 （±5）, and 90 （±7）. Cosmetic outcomes were independently assessed via visual analogue scale （VAS） score evaluations of blinded incision photographs （primary endpoint） and surgeon-assessed modified Hollander Scale （mHCS） scores （secondary endpoint）. SSI assessments used both CDC criteria and ASEPSIS scores.Results Six Chinese hospitals randomized 101 women undergoing modified radical mastectomy to closure with coated VICRYL＊ Plus suture （n=51） or Chinese silk suture （n=50）. Mean VAS cosmetic outcome scores for antibacterial suture （67.2） were better than for Chinese silk （45.4） at day 30 （P 〈0.0001））. Mean mHCS cosmetic outcome total scores, were also higher for antibacterial suture （5.7） than for Chinese silk （5.0） at day 30 （P=0.002）.Conclusions Patients using coated VICRYL＊ Plus suture had significantly better cosmetic outcomes than those with Chinese silk sutures. Patients using coated VICRYL＊ Plus suture had a lower SSI incidence compared to the Chinese silk sutures, although the difference did not reach statistical significance. （ClinicalTrials.gov NCT 00768222）展开更多
Magnesium alloys are considered the most suitable absorbable metals for bone fracture fixation implants.The main challenge in absorbable magnesium alloys is their high corrosion/degradation rate that needs to be contr...Magnesium alloys are considered the most suitable absorbable metals for bone fracture fixation implants.The main challenge in absorbable magnesium alloys is their high corrosion/degradation rate that needs to be controlled.Various coatings have been applied to magnesium alloys to slow down their corrosion rates to match their corrosion rate to the regeneration rate of the bone fracture.In this review,a bioactive coating is proposed to slow down the corrosion rate of magnesium alloys and accelerate the bone fracture healing process.The main aim of the bioactive coatings is to enhance the direct attachment of living tissues and thereby facilitate osteoconduction.Hydroxyapatite,collagen type I,recombinant human bone morphogenetic proteins 2,simvastatin,zoledronate,and strontium are six bioactive agents that show high potential for developing a bioactive coating system for high-performance absorbable magnesium bone implants.In addition to coating,the substrate itself can be made bioactive by alloying magnesium with calcium,zinc,copper,and manganese that were found to promote bone regeneration.展开更多
Absorbable metals have been widely tested in various in vitro settings using cells to evaluate their possible suitability as an implant material.However,there exists a gap between in vivo and in vitro test results for...Absorbable metals have been widely tested in various in vitro settings using cells to evaluate their possible suitability as an implant material.However,there exists a gap between in vivo and in vitro test results for absorbable materials.A lot of traditional in vitro assessments for permanent materials are no longer applicable to absorbable metallic implants.A key step is to identify and test the relevant microenvironment and parameters in test systems,which should be adapted according to the specific application.New test methods are necessary to reduce the difference between in vivo and in vitro test results and provide more accurate information to better understand absorbable metallic implants.In this investigative review,we strive to summarize the latest test methods for characterizing absorbable magnesium-based stent for bioabsorption/biodegradation behavior in the mimicking vascular environments.Also,this article comprehensively discusses the direction of test standardization for absorbable stents to paint a more accurate picture of the in vivo condition around implants to determine the most important parameters and their dynamic interactions.展开更多
Background： To avoid the irritation of tendons and soft tissues as well as hardware-related problems, we designed an intramedullary fixation with bioabsorbable rods for the treatment of the metacarpal shaft fractures...Background： To avoid the irritation of tendons and soft tissues as well as hardware-related problems, we designed an intramedullary fixation with bioabsorbable rods for the treatment of the metacarpal shaft fractures. Methods： Five patients with nine shaft fractures of the fourth and fifth metacarpi were treated with intramedullary absorbable implants and followed up with an average of 4.2 months postoperatively. Results： At final follow-up, all patients achieved fracture union with no signs of inflammatory or subcutaneous effusion. There was no shortening, angulatory, or rotatory deformity. There was almost full active extension range of motion （ROM） of the metacarpophalangeal joints while the active flexion ROM of these joints was 80.7 ± 9.6°. hand was 94.0 ± 9.6%. X-rays showed that the arch of the second Compared with the contralateral hand, the grip strength of the injured to fifth metacarpal heads was smooth. There were no intramedullary lytic changes and soft tissue swellings. Conclusion： The intramedullary absorbable implants are a safe, simple, and practical treatment for fourth and filth metacarpal fractures with good early clinical outcomes and no significant complications.展开更多
The adoption of grammatical modifier for im- plants or other kinds of biomaterials eventually absorbed by the body has been a long-standing confusing issue, and there are diverse terms in the large fields of research,...The adoption of grammatical modifier for im- plants or other kinds of biomaterials eventually absorbed by the body has been a long-standing confusing issue, and there are diverse terms in the large fields of research, which not only causes the difficulties when searching on the Internet, but also blurs the meaning and boundaries for researchers. Prior unification attempts at laws/standards set the basis for such research fields towards researching, labeling, marketing and instructions for use. Considering this, the typical gram- matical modifiers ＂biodegradable＂, ＂resorbable＂ ＂absorbable＂, along with their noun forms used in the decades of scien- tific research have been reviewed and explained, interdiscipli- nary in chemistry, ecology, materials science, biology, micro- biology, medicine, and based on usage customs, laws, stan- dards and markets. The term ＂biodegradable＂ has been not only used in biomaterials but also in ecology waste manage- ment, biomedicine and even natural environment. Mean- while, the term ＂resorbable＂ has long been used in biological reaction （osteoclast driven bone resorption）, but is inappro- priate for implants that do not carry the potential to grow back into their original form. The term ＂absorbable＂ focuses more on the host metabolism to the foreign biodegradation products of the implanted material/device compared with the term ＂degradable/biodegradable＂. Meanwhile the coherence and normalization of the term ＂absorbable＂ carried by its own in laws and standards contributes as well. In general, the au- thors consider the term ＂absorbable＂ to be the best grammat- ical modifier with respect to other adjectives which share the same inherence. A further internationally unified usage is proposed by us.展开更多
Objective： To study the effect of internal fixation with absorbable pins on treatment of displaced radial head fractures. Methods： From May 1999 to May 2004, 16 patients with displaced radial head fractures （Mason...Objective： To study the effect of internal fixation with absorbable pins on treatment of displaced radial head fractures. Methods： From May 1999 to May 2004, 16 patients with displaced radial head fractures （Mason types Ⅱ and Ⅲ） were treated with internal fixation by absorbable pins. The duration of follow-up averaged 22.6 months （12-58 months）. The outcome was assessed on the basis of elbow motion, radiographic findings and the functional rating score delineated by Broberg and Morrey. Results： All fractures healed within 10 months without avascular necrosis of radial head. The mean elbow flexion loss was 15°（0°-35°） , and pronation and supination decreased by 10°（ 0°-30°） on average compared with those of the contralateral elbow. Five patients had an excellent result, 6 a good result, and 3 a fair result according to the criteria of Borberg and Morrey. Conclusions： Internal fixation with absorbable pins is an effective method in treating displaced radial head fractures. It can maintain the biomechanical stability of forearm, improve the elbow function and avoid second operation.展开更多
文摘This paper comprehensively explores the technical principles and application practice of Sainaoning absorbable dural sealant medical adhesive in dural closure.It elaborates on the research and development background of Sainaoning,analyzes its composition,action mechanism,and product characteristics in detail,and presents the results of pre-clinical and clinical studies.The application of Sainaoning in different craniotomy surgeries is discussed,and its effectiveness and safety are evaluated.The paper also analyzes the challenges in its application and proposes corresponding countermeasures,aiming to provide a comprehensive understanding and reference for the clinical use and further development of Sainaoning.
文摘AIM: To report a systematic review of published randomized controlled trials(RCTs) investigating the role of absorbable suture(AS) against non-AS(NAS) used for the closure of surgical incisions.METHODS: RCTs investigating the use of AS vs NAS for the closure of surgical incisions were statistically analysed based upon the principles of meta-analysis and the summated outcomes were represented as OR.RESULTS: The systematic search of medical literature yielded 10 RCTs on 1354 patients. Prevalence of wound infection(OR = 0.97; 95%CI: 0.56, 1.69; Z = 0.11; P = 0.92) and operative morbidity(P = 0.45) was comparable in both groups. Nonetheless, the use of AS lead to lower risk of wound break-down(OR = 0.12; 95%CI: 0.04, 0.39; Z = 3.52; P 【 0.0004).CONCLUSION: This meta-analysis of 10 RCTs demonstrates that the use of AS is similar to NAS for skin closure for surgical site infection and other operative morbidities. AS do not increase the risk of skin wound dehiscence,rather lead to a reduced risk of wound dehiscence compared to NAS.
文摘Paraesophageal hernia(PEH)repair is one of the most challenging upper gastrointestinal operations.Its high rate of recurrence is due mostly to the low quality of the crura and size of the hiatal defect.In an attempt to diminish the recurrence rates,some clinical investigators have begun performing meshreinforced cruroplasty with nonabsorbable meshes like polypropylene or polytetrafluoroethylene.The main problem with these materials is the occurrence,in some patients,of serious mesh-related morbidities,such as erosions into the stomach and the esophagus,some of which necessitate subsequent esophagectomy or gastrectomy.Absorbable meshes can be synthetic or biological and were introduced in recent years for PEH repair with the intent of diminishing the recurrence rates observed after primary repair alone but,theoretically,without the risks of morbidities presented by the nonabsorbable meshes.The current role of absorbable meshes in PEH repair is still under debate,since there are few data regarding their long-term efficacy,particularly in terms of recurrence rates,morbidity,need for revision,and quality of life.In this opinion review,we analyze all the presently available evidence of reinforced cruroplasty for PEH repair using nonabsorbable meshes(synthetic or biological),focusing particularly on recurrence rates,mesh-related morbidity,and long-term quality of life.
文摘In order to improve the success rate of chronic total occlusion (CTO)percutaneous coronary intervention (PCI), retrograde approach has been attracted more attention.Recent study reported the collateral perforation rate was 6.9% in retrograde CTO PCI.[1,2] Collateral related perforations were higher in patients with the epicardial collateral than that with the septal collateral.[3]Several techniques have been developed to deal with the collateral branch perforation.Here,we described the treatment of epicardial collateral branch perforation by absorbable suture segments embolization through microcatheter during retrograde CTO PCI.
基金Supported by the National Natural Science Foundation of China(No.82060181)General Project funded by the Jiangxi Provincial Department of Education(No.GJJ2200194).
文摘AIM:To investigate the biomechanical properties and practical application of absorbable materials in orbital fracture repair.METHODS:The three-dimensional(3D)model of orbital blowout fractures was reconstructed using Mimics21.0 software.The repair guide plate model for inferior orbital wall fracture was designed using 3-matic13.0 and Geomagic wrap 21.0 software.The finite element model of orbital blowout fracture and absorbable repair plate was established using 3-matic13.0 and ANSYS Workbench 21.0 software.The mechanical response of absorbable plates,with thicknesses of 0.6 and 1.2 mm,was modeled after their placement in the orbit.Two patients with inferior orbital wall fractures volunteered to receive single-layer and double-layer absorbable plates combined with 3D printing technology to facilitate surgical treatment of orbital wall fractures.RESULTS:The finite element models of orbital blowout fracture and absorbable plate were successfully established.Finite element analysis(FEA)showed that when the Young’s modulus of the absorbable plate decreases to 3.15 MPa,the repair material with a thickness of 0.6 mm was influenced by the gravitational forces of the orbital contents,resulting in a maximum total deformation of approximately 3.3 mm.Conversely,when the absorbable plate was 1.2 mm thick,the overall maximum total deformation was around 0.4 mm.The half-year follow-up results of the clinical cases confirmed that the absorbable plate with a thickness of 1.2 mm had smaller maximum total deformation and better clinical efficacy.CONCLUSION:The biomechanical analysis observations in this study are largely consistent with the clinical situation.The use of double-layer absorbable plates in conjunction with 3D printing technology is recommended to support surgical treatment of infraorbital wall blowout fractures.
文摘To develop a new generation of absorbable fracture fixation devices with enhanced biocompatibility, the biodegradation mechanism and its influence on the cellular response at the tissue/implant interface of hydroxyapatite/ poly DL lactide (HA/PDLLA) composites were investigated in vitro and in vivo.HA/PDLLA rods were immersed in phosphate buffered saline,or implanted in muscle and bony tissue for 52 weeks.Scanning electron microscopic and histological studies were done.The degradation rate was the slowest in vitro,slower in muscle tissue and fast in bone.In vitro, the composites degraded heterogeneously and a hollow structure was formed.In bone,the limited clearing capacity leads to the accumulation of oligomeric debris,which contribute totally to the autocatalytic effect.So,the fastest degradation and intense tissue response were seen.In muscle tissue,oligomeric debris migrated into vicinal fibers over a long distance from the original implant cavity and the tissue reactions were,however, quite moderate.For the same size organic/inorganic composite,the environment where it was placed is the major factor in determining its biodegradation process and cellular reaction.In living tissue,factors such as cells,enzymes and mechanical stress have an obvious influence on the biodegradation and biological process at the tissue/implant interface.The biocompatibility of the HA/PDLLA composites is enhanced with the incorporating of the resorbable HA microparticles.
文摘This paper reviewed all types of the polymer - based synthetic absorbable surgical sutures that have been commercially produced. The chemical component, biological and mechanical properties, and using effect of these sutures were discussed. The recent development and the possible coming research orientation in these areas were also presented.
文摘Objective:To study the effects of absorbable materials in non-weight-bearing bone fractures of extremities.Methods:After 66 patients with nonweight-bearing bone fractures of extremities were selected,absorbable materials were used in the observation group and metal materials were used in the control group.Results:After treatment,the bone healing in the observation group was significantly improved(P<0.05).Conclusion:the application of absorbable materials in non-weight-bearing bone fractures of extremities is effective.
文摘Objective:To study the trauma and bone metabolism after internal absorbable screw and metal screw fixation treatment of tibia-fibula fracture. Methods:78 patients with tibia-fibula fracture who received internal fixation surgery in our hospital between May 2013 and October 2015 were selected and randomly divided into absorbable group and metal group (n=39) who accepted internal absorbable screw fixation and internal metal screw fixation respectively. 3 d after operation, serum was collected to determine the levels of inflammatory factors, pain mediators, stress hormones and bone metabolism indexes. Results: Serum inflammatory mediators procalcitonin (PCT), Resistin, C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α(TNF-α), pain mediators substance P (SP), prostaglandin E2 (PGE2) and NPY, stress hormones norepinephrine (NE), epinephrine (E) and cortisol (Cor) as well as bone resorption marker molecules C-terminal telopeptides of type I collagen (CTX-I) and C-terminal telopeptides of type II collagen (CTX-II) levels of absorbable group were significantly lower than those of metal group (P<0.05) while bone formation marker molecules N-MID osteocalcin (N-MID) and N-terminal propeptide of procollagen type I (PINP) levels were significantly higher than those of metal group (P<0.05). Conclusions:The trauma degree of internal absorbable screw fixation treatment of tibia-fibula fracture is weaker than that of internal metal screw fixation, and the bone metabolism activity is better than that of internal metal screw fixation.
文摘Objective To observe the degradability of absorbable sutures in tendon grafts and the histology of tendon healing in a rabbit model.Methods Semitendinosus tendons were harvested from 15 healthy adult New Zealand rabbits in this study.
文摘Magnesium alloys present a compelling prospect for absorbable implant materials in orthopedic and trauma surgery.This study evaluates an ultra-high purity,lean magnesium-calcium alloy(X0),both with and without plasma electrolytic oxidation(PEO)surface modification,in comparison to a clinically utilized WE43 magnesium alloy.It is shown that the mechanical properties of X0 can be tuned to yield a high-strength material suitable for bone screws(with an ultimate tensile strength of 336 MPa)or a ductile material appropriate for intraoperatively deformable plates(with an elongation at fracture of 24%).Four plate-screw combinations were implanted onto the pelvic bones of six sheep without osteotomy for 8 weeks.Subsequent analysis utilized histology,micro-computed tomography,and light and electron microscopy.All implants exhibited signs of degradation and hydrogen-gas evolution,with PEO-coated X0 implants demonstrating the least volume loss and the most sub-stantial new-bone formation on the implant surface and surrounding cancellous bone.Furthermore,the osteo-conductive properties of the X0 implants,when uncoated,exceeded those of the uncoated WE43 implants,as evidenced by greater new-bone formation on the surface.This osteoconductivity was amplified with PEO surface modification,which mitigated gas evolution and enhanced osseointegration,encouraging bone apposition in the cancellous bone vicinity.These findings thus indicate that PEO-coated X0 implants hold substantial promise as a biocompatible and absorbable implant material.
基金funded by MedArt Technology Co.,Ltd.,located in Chengdu,China.The company supplied cranial flap fixation products utilized in the study and provided financial support for the research.
文摘Background Absorbable cranial flap fixation products,represented by Aesculap^(®)CranioFix absorbable clamp,are widely used in neurosurgery.However,the product has some shortcomings,as it is not entirely biodegradable,the lower disc’s angle cannot be adjusted,and there is a failure to readjust after fixation.To address these issues,MedArt Technology Co.,Ltd.from China has come up with a high-purity PLLA combined with an innovative structural design to develop a novel cranial flap fixation system that is more convenient to operate,has a better resetting effect,and can be fully absorbed.This study aims to verify its safety and effectiveness through in vitro experiments and clinical trials.Methods In this study,the absorbable cranial flap fixation system of MedArt was used as the experimental group,and the CranioFix absorbable clamp constituted the control group.The material properties and the changing trend of mechanical properties of the two groups were compared by accelerated degradation experiments in vitro.A multicenter,randomized,parallel,positive-controlled,non-inferiority clinical study was conducted with a 48-week follow-up.The shortening degree of the bone flap gap,qualified rate of bone flap displacement,changing trend of implant volume,and occurrence of postoperative adverse events were compared between the two groups.Results The results of the in vitro accelerated degradation showed that in terms of the decrease in intrinsic viscosity,the control and experimental groups took 7 days and 14 days,respectively,to reach the test endpoint.For mechanical properties,the control group and experimental groups lost clinical safety fixation significance on the 3rd and 4th day after the degradation began,respectively.Regarding the release of degradation products,the control group showed a burst of lactic acid release during the first 3-7 days,while the experimental group released lactic acid slowly and constantly.In the clinical study,90 patients were randomly enrolled,87 of whom completed the operation,with an average age of 50.The 3D reconstruction of CT images showed that the bone flap gaps in both groups were less than 2 mm after surgery.The qualified rate of bone flap displacement in the experimental group was 100%after surgery.In contrast,in the control group,there was one unqualified case at 1 week after surgery and two unqualified cases at 6 weeks,12 weeks,24 weeks,and 48 weeks.The residual volume of the implant in the experimental group was closer to 50%(about 48.8%)48 weeks after surgery,than in the control group(about 43.9%)12 weeks after surgery.Regarding safety,only one possible device-related adverse event occurred in the control group,with an incidence rate of 2.22%,manifested as poor healing at the incision site.Conclusions The study has verified that the experimental group had better stability,longer biodegradation time,and better mechanical properties than the control group.Moreover,the experimental group could significantly narrow the cranial flap gap,reduce the flap displacement,and promote skull healing after craniotomy.It shows a fairly reliable fixation effect and safety.
基金supported by the Basic Science Research Center Project of National Natural Science Foundation of China(Grant No.T2288102).
文摘Over the past two decades,advances in arthroscopic and minimally invasive surgical techniques have led to significant growth in sports medicine surgery.Implants such as suture anchors,interference screws,and endo-buttons are commonly used in these procedures.However,traditional implants made of metal or inert materials are not absorbable,leading to complications that affect treatment outcomes.To address this issue,absorbable materials with excellent mechanical properties,good biocompatibility,and controlled degradation rates have been developed and applied in clinical practice.These materials include absorbable polymers,absorbable bioceramics,and absorbable metals.In this paper,we will provide a comprehensive summary of these absorbable materials from the perspective of clinicians,and discuss their clinical applications and related research in sport medicine.
基金supported by the Shanghai Municipal Commission of Health and Family Planning(20144Y0250,20134Y207)the National Natural Science Foundation of China(11302154,11272273)The Hong Kong Research Grant Council GRF(PolyU152216/14E,PolyU5326/11E)
文摘The locking plate and percutaneous crossing metallic screws and crossing absorbable screws have been used clinically to treat intra-articular calcaneal fractures, but little is known about the biomechanical differences between them. This study compared the biomechanical stability of calcaneal fractures fixed using a locking plate and crossing screws. Three-dimensional finite-element models of intact and fractured calcanei were developed based on the CT images of a cadaveric sample. Surgeries were simulated on models of Sanders type III calcaneal fractures to produce accurate postoperative models fixed by the three implants. A vertical force was applied to the superior surface of the subtalar joint to simulate the stance phase of a walking gait. This model was validated by an in vitro experiment using the same calcaneal sample. The intact calcaneus showed greater stiffness than the fixation models. Of the three fixations, the locking plate produced the greatest stiffness and the highest von Mises stress peak. The micromotion of the fracture fixated with the locking plate was similar to that of the fracture fixated with the metallic screws but smaller than that fixated with the absorbable screws. Fixation with both plate and crossing screws can be used to treat intra-articular calcaneal fractures. In general, fixation with crossing metallic screws is preferable because it provides sufficient stability with less stress shielding.
文摘Background The primary objective of this multicenter post-market study was to compare the cosmetic outcome of triclosan-coated VICRYL＊ Plus sutures with Chinese silk sutures for skin closure of modified radical mastectomy. A secondary objective was to assess the incidence of surgical site infection （SSI）.Methods Patients undergoing modified radical mastectomy were randomly assigned to coated VICRYL＊ Plus antibacterial （Polyglactin 910） suture or Chinese silk suture. Cosmetic outcomes were evaluated postoperatively at days 12 （±2） and 30 （±5）, and the evidence of SSI was assessed at days 3, 5, 7, 12 （±2）, 30 （±5）, and 90 （±7）. Cosmetic outcomes were independently assessed via visual analogue scale （VAS） score evaluations of blinded incision photographs （primary endpoint） and surgeon-assessed modified Hollander Scale （mHCS） scores （secondary endpoint）. SSI assessments used both CDC criteria and ASEPSIS scores.Results Six Chinese hospitals randomized 101 women undergoing modified radical mastectomy to closure with coated VICRYL＊ Plus suture （n=51） or Chinese silk suture （n=50）. Mean VAS cosmetic outcome scores for antibacterial suture （67.2） were better than for Chinese silk （45.4） at day 30 （P 〈0.0001））. Mean mHCS cosmetic outcome total scores, were also higher for antibacterial suture （5.7） than for Chinese silk （5.0） at day 30 （P=0.002）.Conclusions Patients using coated VICRYL＊ Plus suture had significantly better cosmetic outcomes than those with Chinese silk sutures. Patients using coated VICRYL＊ Plus suture had a lower SSI incidence compared to the Chinese silk sutures, although the difference did not reach statistical significance. （ClinicalTrials.gov NCT 00768222）
基金supported by the Universiti Kebangsaan Malaysia Research University Grant(GGPM-2020-037,MNS)the Natural Sciences and Engineering Research Council of Canada(RGPIN-2017-04274,HH).
文摘Magnesium alloys are considered the most suitable absorbable metals for bone fracture fixation implants.The main challenge in absorbable magnesium alloys is their high corrosion/degradation rate that needs to be controlled.Various coatings have been applied to magnesium alloys to slow down their corrosion rates to match their corrosion rate to the regeneration rate of the bone fracture.In this review,a bioactive coating is proposed to slow down the corrosion rate of magnesium alloys and accelerate the bone fracture healing process.The main aim of the bioactive coatings is to enhance the direct attachment of living tissues and thereby facilitate osteoconduction.Hydroxyapatite,collagen type I,recombinant human bone morphogenetic proteins 2,simvastatin,zoledronate,and strontium are six bioactive agents that show high potential for developing a bioactive coating system for high-performance absorbable magnesium bone implants.In addition to coating,the substrate itself can be made bioactive by alloying magnesium with calcium,zinc,copper,and manganese that were found to promote bone regeneration.
基金This study was supported by the National Natural Science Foundation of China(Grant No.81330031)Engineering Research Center for Revolutionizing Metallic Biomaterials(NSF-0812348)from the US National Science Foundation+1 种基金China Scholarship Council 2012070000162013 Cultivation Program for the Excellent Doctoral Dissertation of Southwest Jiaotong University.
文摘Absorbable metals have been widely tested in various in vitro settings using cells to evaluate their possible suitability as an implant material.However,there exists a gap between in vivo and in vitro test results for absorbable materials.A lot of traditional in vitro assessments for permanent materials are no longer applicable to absorbable metallic implants.A key step is to identify and test the relevant microenvironment and parameters in test systems,which should be adapted according to the specific application.New test methods are necessary to reduce the difference between in vivo and in vitro test results and provide more accurate information to better understand absorbable metallic implants.In this investigative review,we strive to summarize the latest test methods for characterizing absorbable magnesium-based stent for bioabsorption/biodegradation behavior in the mimicking vascular environments.Also,this article comprehensively discusses the direction of test standardization for absorbable stents to paint a more accurate picture of the in vivo condition around implants to determine the most important parameters and their dynamic interactions.
文摘Background： To avoid the irritation of tendons and soft tissues as well as hardware-related problems, we designed an intramedullary fixation with bioabsorbable rods for the treatment of the metacarpal shaft fractures. Methods： Five patients with nine shaft fractures of the fourth and fifth metacarpi were treated with intramedullary absorbable implants and followed up with an average of 4.2 months postoperatively. Results： At final follow-up, all patients achieved fracture union with no signs of inflammatory or subcutaneous effusion. There was no shortening, angulatory, or rotatory deformity. There was almost full active extension range of motion （ROM） of the metacarpophalangeal joints while the active flexion ROM of these joints was 80.7 ± 9.6°. hand was 94.0 ± 9.6%. X-rays showed that the arch of the second Compared with the contralateral hand, the grip strength of the injured to fifth metacarpal heads was smooth. There were no intramedullary lytic changes and soft tissue swellings. Conclusion： The intramedullary absorbable implants are a safe, simple, and practical treatment for fourth and filth metacarpal fractures with good early clinical outcomes and no significant complications.
基金supported by the National Key Research and Development Program of China (2016YFC1102402)National Natural Science Foundation of China (NSFC, 51431002)the NSFC and the Research Grants Council (RGC) of Hong Kong Joint Research Scheme (51361165101 and 5161101031)
文摘The adoption of grammatical modifier for im- plants or other kinds of biomaterials eventually absorbed by the body has been a long-standing confusing issue, and there are diverse terms in the large fields of research, which not only causes the difficulties when searching on the Internet, but also blurs the meaning and boundaries for researchers. Prior unification attempts at laws/standards set the basis for such research fields towards researching, labeling, marketing and instructions for use. Considering this, the typical gram- matical modifiers ＂biodegradable＂, ＂resorbable＂ ＂absorbable＂, along with their noun forms used in the decades of scien- tific research have been reviewed and explained, interdiscipli- nary in chemistry, ecology, materials science, biology, micro- biology, medicine, and based on usage customs, laws, stan- dards and markets. The term ＂biodegradable＂ has been not only used in biomaterials but also in ecology waste manage- ment, biomedicine and even natural environment. Mean- while, the term ＂resorbable＂ has long been used in biological reaction （osteoclast driven bone resorption）, but is inappro- priate for implants that do not carry the potential to grow back into their original form. The term ＂absorbable＂ focuses more on the host metabolism to the foreign biodegradation products of the implanted material/device compared with the term ＂degradable/biodegradable＂. Meanwhile the coherence and normalization of the term ＂absorbable＂ carried by its own in laws and standards contributes as well. In general, the au- thors consider the term ＂absorbable＂ to be the best grammat- ical modifier with respect to other adjectives which share the same inherence. A further internationally unified usage is proposed by us.
文摘Objective： To study the effect of internal fixation with absorbable pins on treatment of displaced radial head fractures. Methods： From May 1999 to May 2004, 16 patients with displaced radial head fractures （Mason types Ⅱ and Ⅲ） were treated with internal fixation by absorbable pins. The duration of follow-up averaged 22.6 months （12-58 months）. The outcome was assessed on the basis of elbow motion, radiographic findings and the functional rating score delineated by Broberg and Morrey. Results： All fractures healed within 10 months without avascular necrosis of radial head. The mean elbow flexion loss was 15°（0°-35°） , and pronation and supination decreased by 10°（ 0°-30°） on average compared with those of the contralateral elbow. Five patients had an excellent result, 6 a good result, and 3 a fair result according to the criteria of Borberg and Morrey. Conclusions： Internal fixation with absorbable pins is an effective method in treating displaced radial head fractures. It can maintain the biomechanical stability of forearm, improve the elbow function and avoid second operation.
