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临床试验/NCT02533492
NCT02533492已完成4 期

Compare the Results of Antimicrobial to Conventional Suture Materials in Patients Receiving Primary Total Knee Replacement: A Prospective Double-blinded Randomized Controlled Trial

Mel Shiuann-Sheng Lee2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
102
试验地点
2
主要终点
wound infection

研究概览

简要总结

Total knee replacement is now one of the most popular reconstructive procedures for the elderly people to regain their functional capacity and life quality. However the reported incidence of postoperative infection or surgical site infection after total knee replacement has been around 1 to 2 percent. The cost and expenditure for treating periprosthetic infection are high and the results are often detrimental to the patients who suffered from the complication. To decrease the wound healing complication related to the contamination of bacteria, an antibacterial suture was used successfully in some clinical settings and in animal experiments. Whether the antibacterial suture material could be used in patients with total knee replacement has not been addressed in the past. The investigators therefore propose a prospective randomized double-blinded study to investigate the efficacy of an antibacterial suture material in total knee replacement. The inclusion criteria are patients with degenerative osteoarthritis without previous surgery to the index knee. Patients who have inflammatory arthritis such as rheumatoid arthritis, who have neurovascular disease of the lower extremities, who have history of liver cirrhosis or under hemodialysis for renal failure are excluded. One hundred and two patients will be randomized to study group (51 knees) and control group (51 knees) in a period of 12 months. All cases will follow the standard protocol based on clinical pathway. Antibacterial suture material (Vicryl Plus, Ethicon) will be used in the study group and regular suture material (Vicryl, Ethicon) will be used in the control group. Preoperatively, the skin condition (digital photo and image analysis),laser Doppler study, inflammatory markers (CRP/ESR/IL-6), functional score (KSS: Knee Society Score; SF-12: Short Form 12), and VAS score will be assessed. Operative data of operation time, blood loss and wound classification are recorded. Postoperatively, the skin condition (digital photo and image analysis), skin temperature, inflammatory markers, KSS, and VAS will be assessed on 1st and 3rd postoperative day, 2 weeks, 4 weeks, and 3 months.

详细描述

Title of study:

Compare the results of Antimicrobial with Conventional suture materials in patients receiving primary total knee replacement: a prospective double-blinded randomized controlled trial

Objectives:

Primary Objective: To investigate whether the surgical site infection rate after total knee replacement will be different with two different suture materials.

Secondary Objective: To investigate the surrogating markers for inflammatory response and functional outcomes with two different suture materials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Degenerative osteoarthritis
  • Varus/valgus deformity knee

排除标准

  • Inflammatory arthritis
  • Systemic diseases with coagulopathy
  • Immune compromise(ESRD, liver cirrhosis)
  • PAOD or DVT history
  • Pre-OP INR >1.5
  • ASA score >3

结局指标

主要结局

wound infection

时间窗: 3 months

次要结局

  • serum inflammatory marker(3 months)

研究者

发起方
Mel Shiuann-Sheng Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mel Shiuann-Sheng Lee

Chang Gung Memorial Hospital, Dept Orthopedic Surgery

Chang Gung Memorial Hospital

研究点 (2)

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