Vacuum Sealing Drainage (VSD) in Promoting Wound Healing and Reducing Complications in Post-Infected Obstetric and Gynecological Surgical Sites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to complete wound healing
研究概览
简要总结
This study aims to evaluate the efficacy of VSD in promoting wound healing and reducing complications, such as re-infection, prolonged hospitalization, and need for further surgical interventions, in obstetric and gynecological patients who have developed surgical site infections following their primary procedures. The investigators hypothesize that VSD will lead to faster wound healing, fewer complications, and improved patient outcomes compared to conventional wound care in this specific patient 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a surgical site infection (SSI) following an obstetric or gynecological surgical procedure (e.g., Cesarean section, hysterectomy, myomectomy, salpingo-oophorectomy).
- •Wound classification as superficial incisional SSI, deep incisional SSI, or organ/space SSI (if accessible for VSD application).
- •Willingness and ability to provide informed consent.
- •Wound requiring secondary intention healing or delayed primary closure after debridement
排除标准
- •Patients with necrotic tissue.
- •Presence of exposed blood vessels, organs, or anastomotic sites where VSD is contraindicated.
- •Untreated coagulopathy or active bleeding diathesis.
- •Allergy to VSD components or dressing materials.
- •Patients with significant immunosuppression (e.g., uncontrolled HIV, organ transplant recipients on high-dose immunosuppressants).
- •Patients with malignant wounds.
- •Patients who decline participation.
- •Patients requiring immediate primary wound closure without debridement.
- •Patients with a known history of severe psychiatric illness affecting compliance.
研究组 & 干预措施
Conventional Wound Care Group
干预措施: Conventional Wound Care Group (Biological)
Vacuum Sealing Drainage (VSD) Group
干预措施: Vacuum Sealing Drainage (VSD) Group (Biological)
结局指标
主要结局
Time to complete wound healing
时间窗: weekly follow up for one month after procedure
Defined as complete epithelialization of the wound, measured in days
次要结局
未报告次要终点
研究者
Mohamed Hassan Mohamed Abdel Ghfar
Lecturer of Obstetrics and Gynecology
Minia University