Polyurethane Foam Versus Gauze Dressing After Cesarean Delivery in a Standardized Surgical Setting: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Scar Cosmesis assessed by Patient Scar Assessment Scale (PSAS)
研究概览
简要总结
Background:
Cesarean delivery is one of the most frequently performed surgical procedures worldwide, and postoperative scar quality remains an important patient-centered outcome. Advanced dressings such as polyurethane foam are increasingly used to optimize the wound environment; however, evidence supporting their superiority over conventional gauze remains limited. This study aimed to compare the effects of polyurethane foam and gauze dressings on scar outcomes and surgical site infection (SSI) following cesarean delivery.
Methods:
In this prospective, single-blind randomized controlled trial conducted between 2024 and 2025, women undergoing cesarean delivery via Pfannenstiel incision were randomly assigned to receive either polyurethane foam or conventional gauze dressing. All procedures were performed by a single surgeon using a standardized 4-0 rapid Vicryl subcuticular closure technique. Scar outcomes were assessed using the Patient Scar Assessment Scale (PSAS) at 1 week, 1 month, and 6 months postoperatively. The incidence of 30-day SSI was also evaluated.
Although there have been significant advancements in wound dressing materials and techniques, with numerous types of dressings now available, there has been a paucity of studies investigating the efficacy and scar outcomes of these modern dressings specifically in cesarean section, which is classified as a clean wound in obstetric and gynecological surgery. The present study, by incorporating patient scar satisfaction as an outcome measure, will serve as a valuable contribution to evaluating the clinical significance of contemporary wound dressings in this surgical context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Korean women aged 18 years or older who provided written informed consent to participate in the study
- •2. Patients who underwent emergency or elective cesarean section
- •3. Patients with a transverse skin and uterine incision (Pfannenstiel incision)
- •4. Patients who received prophylactic antibiotics (Cefazolin 1g) intravenously 30 minutes prior to surgery
- •5. Patients who completed at least three follow-up visits after discharge
排除标准
- •Patients under 18 years of age
- •2. Patients who did not undergo transverse skin or uterine incision (i.e., vertical incision)
- •3. Use of antibiotics prior to delivery (excluding prophylactic antibiotics administered at delivery)
- •4. Patients taking immunosuppressive drugs
- •5. History of adhesive allergy or allergic skin diseases
- •6. Patients unable to complete the required follow-up schedule
- •7. Patients who did not consent or were unable to understand the study protocol
结局指标
主要结局
Scar Cosmesis assessed by Patient Scar Assessment Scale (PSAS)
时间窗: 1 week post-discharge, 1 month post-operatively, and 6 months post-operatively
Scar cosmesis was evaluated using the Patient Scar Assessment Scale (PSAS), a validated patient-reported outcome measure. The PSAS assesses six subjective scar characteristics: pain, itching, color difference, stiffness, thickness, and irregularity. Each item is scored on a numerical scale from 1 (normal/no symptoms) to 10 (worst imaginable/most different from normal skin), yielding a total score ranging from 6 to 60. A lower score indicates better scar cosmesis.
次要结局
- Incidence of Surgical Site Infection (SSI)(During hospitalization (postoperative day 2 and day 4), 1 week post-discharge, and 1 month post-operatively)
研究者
Yewon Jung
Assistant Professor of Obstetrics and Gynecology
Chungnam National University Sejong Hospital