The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes: a Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Surgical Site Infection (SSI)
研究概览
简要总结
This clinical trial evaluates the effectiveness of amniotic membrane application during cesarean delivery in reducing post-surgical complications and improving wound healing and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The primary questions this study aims to answer are:
- Compared to standard care, Does the amniotic membrane reduce surgical site infections and wound dehiscence?
- Does the amniotic membrane improve patient satisfaction with cosmetic outcomes?
Participants were randomized into two groups: the intervention group received an amniotic membrane application over the cesarean incision site, while the control group underwent cesarean delivery without membrane application. Outcomes were assessed at predefined postoperative intervals, focusing on wound healing, pain levels, and cosmetic satisfaction.
详细描述
This randomized, double-blind, controlled trial investigates the effectiveness of amniotic membrane application in reducing post-cesarean complications, including surgical site infections, wound dehiscence, and scar formation. The trial also assesses its impact on pain management and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The study was conducted between May 2022 and May 2023 at Van Regional Training and Research Hospital.
The amniotic membrane, the innermost layer of the placenta, has regenerative, anti-inflammatory, and antimicrobial properties. Its application during cesarean delivery may offer a cost-effective and autologous intervention to enhance surgical outcomes and patient satisfaction.
Objectives:
Primary Objectives:
- Evaluate whether the amniotic membrane reduces surgical complications, including infections, hematoma, and wound dehiscence.
- Investigate its role in preventing hypertrophic scars and keloids.
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
- Double (Participant, Outcomes Assessor)
盲法说明
No additional parties are masked beyond the Participant and Outcomes Assessor.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-40 years. Undergoing their first cesarean section. Term pregnancies (≥37 weeks of gestation). Elective cesarean delivery performed under spinal anesthesia. Use of the Pfannenstiel incision method. Willing and able to provide written informed consent.
排除标准
- •History of previous abdominal surgeries. Presence of chronic conditions such as diabetes mellitus, hypertension, or vascular diseases.
- •Pulmonary conditions or collagen tissue disorders affecting wound healing. Signs of infection during delivery. Use of medications or therapies that impair wound healing (e.g., corticosteroids, immunosuppressants).
- •Known hypersensitivity to materials or methods used in the study
结局指标
主要结局
Surgical Site Infection (SSI)
时间窗: Time Frame: Within 7 days post-surgery.
Description: The presence of surgical site infections diagnosed based on erythema, induration, tenderness, and purulent discharge. Scale: Binary (Yes/No)
Wound Dehiscence
时间窗: Time Frame: Within 7 days post-surgery.
Description: The occurrence of wound dehiscence defined as a wound gap of less than 1 cm in depth. Scale: Binary (Yes/No).
Scar/Keloid Formation
时间窗: Time Frame: At 40 days and 6 months post-surgery.
Description: The presence of hypertrophic scars or keloids assessed visually. Scale: Binary (Yes/No).
次要结局
- Postoperative Pain (VAS Score)(Time Frame: Postoperative days 1 and 2.)
- Cosmetic Satisfaction(Time Frame: At 40 days post-surgery.)
研究者
Izzet Celegen
Assistant professor
Yuzuncu Yıl University