Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.
研究概览
简要总结
Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.
详细描述
The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women, >=18 and <= 85 years of age, undergoing surgery, via a midline laparotomy.
- •Body mass index >=30
- •Benign or oncologic indications for surgery.
- •Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
- •Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine.
- •Ability to understand and willingness to sign an IRB approved written informed consent document.
排除标准
- •Women who are pregnant or breastfeeding
- •Pfannenstiel or transverse abdominal incision
- •Concomitant panniculectomy or plastic surgery
- •Women <18 years of age
- •History of prior abdominal or pelvic radiation
- •Inability to sign an informed consent form prior to registration on study
- •Inability to understand spoken or written English
- •Mental incapacity
- •A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.
研究组 & 干预措施
Stainless Steel Staples
Skin closure with stainless steel staples
干预措施: Stainless steel staples (Device)
4-0 monofilament Sutures
Skin closure with 4-0 monofilament sutures
干预措施: 4-0 monofilament suture (Device)
结局指标
主要结局
Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.
时间窗: 4-8 weeks post-surgery
次要结局
- Incidence of Wound Disruption(4-8 weeks post-surgery)
- Incidence of Wound Infection(4-8 weeks post-surgery)
- Operative Time(During surgery)
- Analog Pain Score on Postoperative Days 3-4(3-4 days post-surgery)
- Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score(4-8 weeks post-operative)
- Median Patient Satisfaction Score of Scar Appearance(4-8 weeks post-operative)