Compare the Results of Antimicrobial to Conventional Suture Materials in Patients Receiving Primary Total Knee Replacement: A Prospective Double-blinded Randomized Controlled Trial
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
- 否
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
Mel Shiuann-Sheng Lee
Chang Gung Memorial Hospital, Dept Orthopedic Surgery
Chang Gung Memorial Hospital
