Effect of Cesarean Wound Dressing Removal Timing on Wound Healing in Women With BMI ≥ 30 kg/m²
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 726
- 主要终点
- Number of Participants With Surgical Site Infection (SSI)
研究概览
简要总结
Cesarean delivery is one of the most common surgical procedures in obstetric care. Women with obesity (body mass index [BMI] of 30 kg/m² or higher) are at increased risk for postoperative wound complications, including surgical site infections, fluid collections (seroma/hematoma), and wound separation. Postoperative wound dressings protect the surgical incision, but the optimal timing for dressing removal remains uncertain, particularly for high-risk patients.
The purpose of this prospective cohort study is to compare wound healing and the occurrence of surgical site infections between two standard dressing removal schedules in women with a BMI ≥ 30 kg/m² undergoing cesarean delivery.
Participants are observed in one of two groups according to standard hospital practice:
- Group 1: The sterile wound dressing is removed at approximately 48 hours after surgery.
- Group 2: The sterile wound dressing is removed at approximately 5 days after surgery.
Following dressing removal, incisions are assessed for signs of infection, drainage, swelling, and healing progress. The study aims to provide evidence on whether earlier dressing removal at 48 hours is safe and effective compared to delayed removal at 5 days in women with obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 35 years
- •Body mass index (BMI) ≥ 30 kg/m² measured before cesarean delivery or at admission
- •Undergoing cesarean delivery with a Pfannenstiel skin incision and primary skin closure
排除标准
- •Pre-existing infection or inflammation at the planned incision site
- •Active systemic infection or fever prior to surgery
- •Clinical or subclinical chorioamnionitis
- •Major intraoperative contamination of the surgical field
- •Significant preoperative bleeding or anemia
- •Known bleeding or coagulation disorders that may significantly affect wound healing
- •Major postoperative complications requiring additional abdominal surgery
- •Inability or unwillingness to attend scheduled follow-up visits
研究组 & 干预措施
48-Hour Dressing Removal
Women with BMI ≥ 30 kg/m² undergoing cesarean delivery with a Pfannenstiel skin incision whose standardized sterile wound dressing is removed at approximately 48 hours after surgery, followed by clinical wound inspection under aseptic conditions and routine postoperative care.
5-Day Dressing Removal
Women with BMI ≥ 30 kg/m² undergoing cesarean delivery with a Pfannenstiel skin incision whose standardized sterile wound dressing is removed at approximately 5 days after surgery, followed by clinical wound inspection under aseptic conditions and routine postoperative care.
结局指标
主要结局
Number of Participants With Surgical Site Infection (SSI)
时间窗: Up to 48 hours after dressing removal
Number of participants diagnosed with a surgical site infection (SSI) at the Pfannenstiel incision site. Assessment is performed using a standardized clinical wound-assessment form evaluating the presence of purulent discharge, localized erythema, heat, edema, or wound separation.
次要结局
未报告次要终点
研究者
Mohamed Tawfik Abdelmalek Gomaa
Resident
Assiut University