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Cosmetic outcome and surgical site infection rates of antibacterial absorbable （Polyglactin 910） suture compared to Chinese silk suture in breast cancer surgery： a randomized pilot research

引用

Chinese Medical Journal 2011年第5期124卷 719-724页

作者： ZHANG Zhong-tao ZHANG Hong-wei FANG Xue-dong WANG Li-ming LI Xiao-xi LI Ya-fen SUN Xiao-wei judith carver Dorella Simpkins Jessica Shen Martin Weisberg Department of General Surgery Beijing Friendship Hospital Capital Medical University Beijing 100050 China Department of General Surgery Zhongshan Hospital Fudan University Shanghai 200032 China Department of General Surgery Second Hospital Ji/in University Changchun Jilin 130041 China Department of General Surgery Second Hospital Dalian Medical University Dalian Liaoning 116027 China Department of Vascular and Thyroid Surgery The First Affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong 510080 China Department of Breast Surgery Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai 200025 China Strategic Medical Affairs Johnson & Johnson Medical Shanghai Shanghai China Evidence Based Medicine Clinical Development Ethicon Inc. Somerville NJ USA Evidence Based Medicine Clinical Development Medical Affairs Ethicon Inc. Somerville NJ USA

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 *** 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. （*** NCT 00768222）

关键词： antibacterial absorbable suture silk suture cosmesis surgical site infection

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