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
A new sustainable antibacterial surgical suture coated by chitosan-levofloxacin microcapsule(CLM) was developed and characterized in this work.The CLM with a mean diameter of 1.0-10.0 μm was prepared by emulsion solv...A new sustainable antibacterial surgical suture coated by chitosan-levofloxacin microcapsule(CLM) was developed and characterized in this work.The CLM with a mean diameter of 1.0-10.0 μm was prepared by emulsion solvent evaporation method and applied to the silk surgical suture as the main element of antibacterial coating by dipping-rolling coating method.By the agar diffusion method,high anti-microbial efficacy for up to 4 d was observed against either Staphylococcus aureus(S.aureus) or Escherichia coli(E.coli).And the mechanical properties of the new antibacterial suture including knot mechanical properties,bending stiffness,and suture-to-suture friction properties were characterized fulfilling the requirements of surgical sutures,and were superior to the references.展开更多
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）
文摘A new sustainable antibacterial surgical suture coated by chitosan-levofloxacin microcapsule(CLM) was developed and characterized in this work.The CLM with a mean diameter of 1.0-10.0 μm was prepared by emulsion solvent evaporation method and applied to the silk surgical suture as the main element of antibacterial coating by dipping-rolling coating method.By the agar diffusion method,high anti-microbial efficacy for up to 4 d was observed against either Staphylococcus aureus(S.aureus) or Escherichia coli(E.coli).And the mechanical properties of the new antibacterial suture including knot mechanical properties,bending stiffness,and suture-to-suture friction properties were characterized fulfilling the requirements of surgical sutures,and were superior to the references.
