The Outcomes of Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal : Ramdomized Controlled Trial(RCT).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Surgical Site Infection (SSI)
研究概览
简要总结
This randomized controlled trial compares purse-string versus conventional linear skin closure techniques in children undergoing stoma reversal surgery. The primary aim is to assess surgical site infection rates within 30 days and scar cosmesis at 3 months using the Manchester Scar Scale. Fifty patients (25 per group) will be randomized at Assiut University Pediatric Surgery Department to determine if purse-string closure reduces infections and improves scarring.
详细描述
Stoma reversal surgery is commonly performed in pediatric patients, but complications including surgical site infection (SSI), poor scarring, anastomotic leak, paralytic ileus, adhesive intestinal obstruction, bleeding, and incisional hernia remain concerns. The frequency of SSI and scar formation is directly related to the wound closure technique employed.
Skin wounds in stoma reversal are typically closed using conventional linear closure technique; however, this method carries a higher risk of surgical site infections. Studies in adults have demonstrated that purse-string wound closure technique achieves better cosmetic outcomes and reduced risk of SSI compared to conventional linear closure. However, high-quality data comparing these techniques in pediatric populations undergoing stoma reversal is lacking.
This randomized controlled trial will enroll 50 pediatric patients (aged 1 month to 18 years) undergoing stoma reversal at the Pediatric Surgery Department, Assiut University Hospitals. Participants will be randomized using a lottery method in a 1:1 ratio to receive either conventional linear closure (Group A) using simple interrupted Prolene sutures or purse-string closure (Group B) using Vicryl for subcutaneous layers and Prolene for skin in a purse-string technique.
All patients will undergo standard stoma reversal procedures and receive postoperative care per departmental protocols. Wounds will be evaluated after the first dressing change, at hospital discharge, during stitch removal, and at follow-up visits continuing for 3-4 months. Surgical site infection will be assessed using CDC criteria. Scar cosmesis will be evaluated at a minimum of 3 months post-surgery using the Manchester scar scale by three independent assessors.
The study aims to compare the frequency of surgical site infections and cosmetic outcomes between the two closure techniques, providing evidence-based guidance for optimal wound closure in pediatric stoma reversal.
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
- 0 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 month to 18 years undergoing stoma reversal after informed consent obtained from parents.
排除标准
- •Patients with divided stomas .
- •Patients who will lost to follow-up.
- •Patients who will develop anastomotic leakage, organ/space SSI.
研究组 & 干预措施
Conventional Linear Closure Arm
Patients undergo stoma reversal surgery with skin wound closed using conventional linear technique: simple interrupted Prolene sutures after standard internal layer closure. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up.
干预措施: Conventional linear skin closure (Procedure)
Purse-String Closure Arm
Patients undergo stoma reversal surgery with skin wound closed using purse-string technique: internal layers closed standardly, subcutaneous layer with Vicryl purse-string, skin with Prolene purse-string. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up.
干预措施: Purse-string skin closure (Procedure)
结局指标
主要结局
Surgical Site Infection (SSI)
时间窗: Up to 30 days post-surgery
Occurrence of SSI at stoma reversal site, defined per CDC criteria (purulent drainage, positive culture, or signs/symptoms of infection treated with antibiotics), assessed by surgeon at dressing changes, discharge, stitch removal, and patient-reported symptoms.
次要结局
- Scar Cosmesis by Manchester Scar Scale(Minimum 3 months post-surgery)
研究者
Abdallah Ali Abdallah Hussein
Resident at Pediatric Surgery Department, Assiut University
Assiut University