Closing Linear Incisions in Plastic Surgery: A Randomized Clinical Trial Comparing a New Coaptive Film Device Versus Standard Subcuticular Sutures for Scar Quality, Patient Comfort, and Closure Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Scar Quality at 6 Months Postoperative
研究概览
简要总结
Purpose: The aims of this randomized clinical trial are:
- to assess scar quality from the patient and surgeon perspectives
- to assess patient comfort in the days immediately following surgery
- to assess the time taken to complete closure in the operating room.
- the financial benefit or cost for the institution of using Steri Strip S will also be estimated.
Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus standard subcuticular sutures. The linear incisions will include the standard incision segments utilized for an inverted-T closure for bilateral breast reduction and the transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest.
Our hypothesis is that incisions segments closed with Steri Strip S compared to standard subcuticular closure, will yield scars of better cosmetic quality, in shorter time to closure, with novice and expert surgeons, for both bilateral breast reduction and abdominoplasty surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients are eligible for enrollment if they agree to provide informed consent, are at least 18 years of age, in generally good health, and available for follow-up in the 5-7 month time frame.
排除标准
- •Women known to be pregnant, minors, patients potentially incompetent to provide informed consent or complete the surveys described in our protocol will be excluded from this trial.
结局指标
主要结局
Scar Quality at 6 Months Postoperative
时间窗: 6 months
Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.
Time to Perform Wound Closure
时间窗: intraoperatively
Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture
次要结局
- Patient Postoperative Incisional Comfort(10 days)