Skin Staples Versus Polypropylene for Skin Closure in Elective Laparotomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
Surgical site infection (SSI) is one of the most common postoperative complications following elective laparotomy and contributes significantly to patient morbidity, prolonged hospital stay, and increased healthcare costs. Various techniques are available for skin closure, including skin staples and polypropylene sutures; however, evidence regarding their comparative effectiveness remains inconsistent, particularly in low- and middle-income countries.
This randomized controlled trial aims to compare skin staples with polypropylene sutures for skin closure following elective laparotomy. Eligible adult patients undergoing elective laparotomy at the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), Islamabad, will be randomly allocated in a 1:1 ratio to receive either skin staples or polypropylene sutures.
The primary outcomes are skin closure time and incidence of surgical site infection within 30 days of surgery. Secondary outcomes include wound dehiscence, postoperative pain, cosmetic scar appearance, patient satisfaction, and duration of hospital stay.
The findings will provide evidence regarding the optimal skin closure technique for elective laparotomy in the Pakistani population.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 15-50 years Elective laparotomy ASA I-III Written informed consent Male or female
排除标准
- •Emergency surgery Previous SSI Recurrent surgery BMI <18 or >30 kg/m² Haemoglobin <10 g/dL COPD Stroke Renal failure Liver disease Haematological disorders Malignancy Immunocompromised state Active infection Previous chemotherapy Previous radiotherapy Malnutrition
结局指标
主要结局
Surgical site infection
时间窗: 30 days
SSI occurring within 30 postoperative days based on CDC clinical criteria with wound culture where indicated.
次要结局
- Skin closure time(During the surgery)
- Wound Dehiscence(30 days)
- Post-operative pain(7 days)
- Scar appearance(6 weeks)
研究者
Muhammad Fahad Ali
Dr Muhammad Fahad Ali
Pakistan Institute of Medical Sciences