Evaluating the Use of Antibiotic-Coated Braided Sutures in Debridement, Antibiotic, and Implant Retention (DAIR) Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Proportion of patients with treatment failure at 90 days
研究概览
简要总结
The purpose of this study is to evaluate whether the use of antibiotic-coated (triclosan) braided sutures is non-inferior or potentially superior to standard monofilament sutures in patients with prosthetic joint infections (PJIs) managed with the DAIR protocol. Several studies in various surgical specialties have demonstrated the effectiveness and non-inferiority of triclosan-coated braided sutures in infected surgical cases, and the study intends to transpose this idea to the management of prosthetic joint infections. Monofilament sutures are the present standard of care in any infected joint case due their lower surface area for bacterial harborization, though surgeons sacrifice mechanical integrity and comfortability with the closure in the process. By demonstrating the safety of antibiotic -coated braided sutures, surgeons will no longer have to make this compromise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Willing and able to provide informed consent
- •Primary Total Hip Arthroplasty or Total Knee Arthroplasty with Prosthetic Joint Infection Musculoskeletal Infection Society (MSIS) criteria
- •Prosthetic Joint Infection Treated with Debridement, Antibiotics, Implant Retention
- •Acute Prosthetic Joint Infection: <4 weeks since it was suspected/diagnosed
排除标准
- •Staphylococcus aureus bacteremia
- •Mycobacterial, fungal, or parasitic infection
- •Concurrent infection needing prolonged Intravenous therapy
- •Septic shock/systemic illness needing IV therapy
- •Patients with severe immunosuppression (ex: chemotherapy,
- •neutropenia, HIV, steroid use
- •Allergy to Triclosan
- •Pregnancy
- •Prisoners
研究组 & 干预措施
Triclosan-Braided Suture Group
Patients randomized to this arm will receive triclosan-coated braided sutures for closure of the fascia. Following incision and full debridement and irrigation, the fascia will be closed with this suture. Suturing of the fascia typically takes ~10 minutes. As this suture is absorbable, it does not have to be removed. The superficial layers of the skin will be closed with nylon suture.
干预措施: VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial) (Device)
Monofilament Suture Group
Patients randomized to this arm will receive monofilament sutures for closure of the fascia. Following incision and full debridement and irrigation, the fascia will be closed with this suture. Suturing of the fascia typically takes ~10 minutes. As this suture is absorbable, it does not have to be removed. The superficial layers of the skin will be closed with nylon suture.
干预措施: Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament (Device)
结局指标
主要结局
Proportion of patients with treatment failure at 90 days
时间窗: 90 days post treatment
Treatment failure is defined by Musculoskeletal Infection Society Criteria for prosthetic joint infection, including persistent wound drainage, sinus tract formation, positive cultures, or need for surgical revision.The proportion will be calculated as the number of patients meeting any MSIS treatment-failure criterion divided by the total number of patients evaluated. Assessment will be based on clinical evaluation and microbiological data collected at 90 days post-treatment.
次要结局
- Incidence of Superficial Site Infection(Up to 90 days post-operative)
- Net Cost Comparison of Triclosan-Coated Braided vs. Monofilament Sutures (USD per patient)(Within 90 days of surgery)
- Incidence of Wound Dehiscence(Up to 90 days post-operative)
- Incidence of Delayed Wound Healing(Up to 90 days post-operative)
- Incidence of Seroma Formation(Up to 90 days post-operative)
研究者
Colin A. McNamara
Assistant Professor
University of Miami