中华医学杂志（英文版）2011，Vol.124Issue(5)：719-724,6.DOI:10.3760/cma.j.issn.0366-6999.2011.05.016
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
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
ZHANG Zhong-tao 1Jessica Shen 2Martin Weisberg 3ZHANG Hong-wei 4FANG Xue-dong 5WANG Li-ming 6LI Xiao-xi 7LI Ya-fen 8SUN Xiao-wei 9Judith Carver 2Dorella Simpkins2
作者信息
- 1. Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
- 2. Evidence Based Medicine, Clinical Development, Ethicon Inc., Somerville, NJ, USA
- 3. Evidence Based Medicine, Medical Affairs, Ethicon Inc., Somerville, NJ, USA
- 4. Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China
- 5. Department of General Surgery, Second Hospital, Jilin University, Changchun, Jilin 130041, China
- 6. Department of General Surgery, Second Hospital, Dalian Medical University, Dalian, Liaoning 116027, China
- 7. Department of Vascular and Thyroid Surgery, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510080, China
- 8. Department of Breast Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
- 9. Strategic Medical Affairs, Johnson & Johnson Medical Shanghai, Shanghai, China
- 折叠
摘要
Abstract
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)关键词
antibacterial/absorbable suture/silk suture/cosmesis/surgical site infectionKey words
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ZHANG Zhong-tao,Jessica Shen,Martin Weisberg ,ZHANG Hong-wei,FANG Xue-dong,WANG Li-ming,LI Xiao-xi,LI Ya-fen,SUN Xiao-wei,Judith Carver,Dorella Simpkins..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[J].中华医学杂志（英文版）,2011,124(5):719-724,6.
