A Comparative Study of Primary Versus Delayed Wound Closure Using the High-Efficiency Incision and Drainage With Irrigation (HIEDI) Technique to Minimize Surgical Site Infection (SSI) Risk in Patients Undergoing Complicated Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Incidence of Surgical Site Infection (SSI) at 30 Days
研究概览
简要总结
The goal of this clinical trial is to compare primary wound closure (PC) versus delayed primary closure (DPC) after standardized wound decontamination using the High-Efficiency Incision and Drainage with Irrigation (HIEDI) technique in patients undergoing open appendectomy for complicated appendicitis in Sana'a, Yemen.
The main questions it aims to answer are:
- Does primary closure with HIEDI result in a non-inferior or lower incidence of Surgical Site Infection (SSI) at 30 days compared with delayed primary closure with HIEDI?
- Does primary closure with HIEDI reduce length of hospital stay and improve the trajectory of objective wound healing compared with delayed primary closure with HIEDI?
- What is the impact of each closure method on patient satisfaction and health-related quality of life?
Researchers will compare the two groups to determine the optimal, evidence-based standard of care for wound management in complicated appendicitis within a resource-limited setting.
Participants will:
- Undergo open appendectomy for intraoperatively confirmed complicated appendicitis (perforation or gangrene).
- Receive standardized HIEDI wound decontamination (meticulous debridement and pulsatile irrigation with minimum 500 mL povidone-iodine 1:10 solution).
- Be randomly allocated to either primary closure (all layers closed at surgery) or delayed primary closure (skin/subcutaneous tissue left open and closed 3-5 days later).
- Attend follow-up visits at days 7, 14, and 30 for wound assessment, infection surveillance, and outcome evaluation.
详细描述
Complicated appendicitis (perforation or gangrene) is a significant cause of postoperative morbidity worldwide. Surgical Site Infection (SSI) is the most common complication, with reported rates exceeding 30% in low- and middle-income countries (LMICs). In Sana'a, Yemen, local data from Al-Thawra Modern General Hospital documented a 27.5% SSI rate specifically in this patient population. The optimal wound closure strategy-primary closure (PC) versus delayed primary closure (DPC)-remains debated, with previous studies yielding conflicting results largely due to lack of standardized intraoperative wound decontamination.
The High-Efficiency Incision and Drainage with Irrigation (HIEDI) technique is a standardized, aggressive decontamination protocol combining meticulous debridement of wound edges with pulsatile high-pressure irrigation using a minimum of 500 mL of povidone-iodine solution (1:10 dilution). By applying HIEDI uniformly to both study arms, this trial isolates the effect of closure timing on SSI risk.
This is a prospective, multicenter, parallel-group, 1:1 randomized controlled superiority trial with blinded outcome assessment, conducted at three tertiary care hospitals in Sana'a, Yemen. The findings will provide high-level, locally generated evidence to establish a safe, resource-conscious standard of care for Yemen and similar settings.
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)
盲法说明
Due to the visible nature of the surgical interventions, blinding of surgeons and patients is not feasible. Outcome assessors evaluating Surgical Site Infection (SSI), data analysts, and laboratory personnel processing wound cultures are blinded to treatment allocation. Group assignments are coded as Group A and Group B until primary analysis is complete.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 years and older
- •Intraoperative diagnosis of complicated appendicitis (perforation or gangrene)
- •Undergoing open appendectomy via McBurney or Rocky-Davis incision
- •Ability to provide written informed consent (patient or legal guardian for minors)
- •Availability for 30-day follow-up
排除标准
- •Generalized peritonitis requiring midline laparotomy
- •Immunocompromised status (e.g., chronic corticosteroid or immunosuppressive therapy, diagnosed HIV infection)
- •Poorly controlled diabetes mellitus (Hemoglobin A1c [HbA1c] greater than 8%)
- •Pregnancy
- •Concurrent malignancy
- •American Society of Anesthesiologists (ASA) physical status classification IV or V
- •Laparoscopic appendectomy
结局指标
主要结局
Incidence of Surgical Site Infection (SSI) at 30 Days
时间窗: Up to 30 days postoperatively
Surgical Site Infection (SSI) diagnosed according to Centers for Disease Control and Prevention (CDC) criteria, classified as superficial incisional, deep incisional, or organ/space infection. Assessed by trained outcome assessors blinded to treatment allocation.
次要结局
- Objective Wound Healing Trajectory (ASEPSIS Score)(Day 7, Day 14, and Day 30 postoperatively)
- Length of Hospital Stay (days)(From admission to discharge, assessed up to 30 days)
- Incidence of Other Postoperative Complications(Up to 30 days postoperatively)
- Patient Satisfaction Score (0-100 scale)(Day 7, Day 14, Day 30)
- Health-Related Quality of Life (EQ-5D-5L score)(Day 7, Day 14, Day 30)
研究者
Haitham Mohammed Jowah
Lecturer
Sana'a University