Comparison of Vicryl Versus Prolene Sutures in Closure of Midline Rectus Sheath Following Elective Laparotomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Incidence of Surgical Site Infection within 30 Days Post-Laparotomy
研究概览
简要总结
This randomized controlled trial compared two commonly used suture materials, Prolene and Vicryl, for closing the midline rectus sheath after elective laparotomy. Proper closure of the abdominal wall is important to reduce complications such as wound dehiscence and surgical site infection. Adult patients undergoing elective midline laparotomy were randomly assigned to rectus sheath closure using either Prolene or Vicryl sutures. All patients received the same standardized surgical technique and postoperative care. Participants were followed for 30 days after surgery to assess wound healing, wound dehiscence, surgical site infection, and length of hospital stay. The study aimed to determine which suture material is associated with fewer postoperative wound complications.
详细描述
This prospective randomized controlled trial was conducted in the Department of General Surgery at Hayatabad Medical Complex, Peshawar. The study enrolled adult patients aged 18 to 70 years who underwent elective midline laparotomy for various abdominal conditions. Patients with malnutrition or anemia (hemoglobin < 10 g/dL), immunocompromised states, active infection, pregnancy, prior chemotherapy or radiotherapy, or previous midline laparotomy were excluded.
A total of 152 patients were randomly allocated into two equal groups. Group A underwent midline rectus sheath closure using Prolene 1 (polypropylene, non-absorbable monofilament) suture, while Group B underwent closure using Vicryl 1 (polyglactin 910, absorbable braided) suture. Randomization was performed using a simple randomization method. In both groups, a standardized continuous mass closure technique was used, maintaining a suture-to-wound length ratio of 4:1 with small bites taken at regular intervals. Skin closure was performed using interrupted non-absorbable sutures.
All surgeries were performed under the supervision of senior specialist surgeons, and standard perioperative care, including antibiotic prophylaxis and postoperative wound care, was provided. Patients were followed for 30 days after surgery through inpatient observation and outpatient follow-up visits. Wounds were assessed clinically for evidence of wound dehiscence and surgical site infection.
The primary outcome measure was the incidence of wound dehiscence within 30 days postoperatively. Secondary outcome measures included surgical site infection and length of hospital stay. Data were collected using a structured proforma and analyzed using statistical software. The study was approved by the institutional ethical review board and conducted in accordance with ethical principles for human research.
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
- None
盲法说明
This is an open-label study as the operating surgeon is aware of the suture material used.
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Patients undergoing elective midline laparotomy
- •Ability to provide written informed consent
排除标准
- •Emergency laparotomy
- •Previous abdominal mesh placement
- •Immunocompromised patients
- •Pregnant women
研究组 & 干预措施
Vicryl Suture Group
Participants undergoing elective midline laparotomy will have rectus sheath closure performed using Vicryl (polyglactin 910) suture material according to standard surgical technique.
干预措施: Vicryl (Polyglactin 910) Suture (Device)
Prolene Suture Group
Participants undergoing elective midline laparotomy will have rectus sheath closure performed using Prolene (polypropylene) suture material according to standard surgical technique.
干预措施: Prolene (Polypropylene) Suture (Device)
结局指标
主要结局
Incidence of Surgical Site Infection within 30 Days Post-Laparotomy
时间窗: 30 days
Surgical site infection (SSI) is defined as purulent discharge, erythema, or positive microbiology from the incision site within 30 days postoperatively. All infections will be classified and documented according to CDC guidelines.
Incidence of Wound Dehiscence within 30 Days Post-Laparotomy
时间窗: 30 days postoperatively
Wound dehiscence is defined as the separation of the rectus sheath or wound edges, including partial or complete dehiscence, observed within 30 days after midline laparotomy. Clinical examination will be used to assess wound integrity, and findings will be documented in the patient's medical record.
次要结局
未报告次要终点
研究者
Yousaf Jan
Associate Professor
Hayatabad Medical Complex
