A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participants With Incisional Drainage, Swelling or Gaps of Incision
研究概览
简要总结
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.
详细描述
Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Patient is 18 years or older
- •Patient or legal representative is able to understand and provide signed consent for the procedure
- •Patient is willing and able to return for required follow-up visits
- •Patient needs a total hip arthroplasty surgical procedure
排除标准
- •Patient has an active infection
- •Patient is enrolled in another similar study
- •Patient has a known history of hepatitis
- •Patient has a known history of HIV
- •Patient has a known history of AIDs
- •Patient has a known history of IV drug abuse
研究组 & 干预措施
Insorb staples
Subcuticular Absorbable staples
干预措施: Insorb staples (Device)
Control
Metal staple wound closure
干预措施: metal staples (Ethicon metal stapler) (Device)
结局指标
主要结局
Participants With Incisional Drainage, Swelling or Gaps of Incision
时间窗: Discharge from initial hospital stay (2-5 days post-op)
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
次要结局
- Participants With Wound Complications - Hematoma(up to 6 weeks post-op)