Prospective, Randomized Clinical Trial Assessing Post-operative Wound Healing Complications Following Total Joint Arthroplasty When Using Bandgrip Incision Closure Compared to Standard Suture Closure
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients with wound healing complications
研究概览
简要总结
Total Joint Arthroplasty (TJA) has become one of the most performed elective procedures. While the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". Following surgery, wound drainage or other wound complications can lead to increased cost and decreased patient satisfaction. Secure wound closure is an important step in preventing wound-related complications. The surgical incision should be closed in a manner that prevents the wound edges from separating which could lead to possible drainage and bacterial contamination of the incision.
Traditional incision closure following TJA includes sutures. These sutures are then removed in the office. BandGrip is a wound closure device that can be used to approximate skin edges of wounds from surgical incisions and traumatic lacerations. It is a bandage-type patch with several small skin anchors that are used to hold the skin edges together. The clear microanchors are 0.029 inches in height and do not puncture through the dermis. There is no need for medical removal as the patient can remove the bandage.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female greater than 18 years of age
- •Scheduled to undergo primary total knee or total hip replacement
- •Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule
排除标准
- •Prior surgical incision or scar in close proximity of the proposed incision (<2 cm).
- •Local skin conditions such as dermatitis, eczema, or psoriasis.
- •Active or previous infection in the skin or the hip or knee to be operated.
- •Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use
- •Subject has a recent history of bleeding, coagulation and/or clotting disorders
- •Subject has a known allergy to BandGrip material (polycarbonate)
结局指标
主要结局
Number of patients with wound healing complications
时间窗: From time of surgery to 30 days post-op
All wound-related complication following surgery
次要结局
- Closure time of surgical wound(Procedure (The time from the first skin pass with the suture needle until the time the last suture knot is tied will be recorded in seconds))