NCT07280975

Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure

Comparative Outcomes of Polyglactin Versus Polypropylene Sutures for Rectus Sheath Closure: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Lady Reading Hospital, Pakistan · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy. The study will evaluate the rates of incisional hernia, surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. Participants aged 18-70 years, undergoing either elective or emergency laparotomy, will be randomly assigned to receive either Polyglactin or Polypropylene sutures. The primary outcome measure is the incidence of incisional hernia at 6 months, with secondary outcomes including SSI, wound complications, and chronic pain. The study is particularly important in the context of Pakistan, where such comparative data is limited, and aims to provide evidence-based recommendations for optimal suture material selection in general surgery.

Detailed description

Study Design This randomized controlled trial is designed to compare the outcomes of two suture materials-Polyglactin 910 (Vicryl) and Polypropylene (Prolene)-for rectus sheath closure after midline laparotomy. The study will be conducted at the Department of General Surgery, Lady Reading Hospital, Peshawar, over 12 months. Participants will be randomly assigned to two groups: Group A (Polyglactin) and Group B (Polypropylene). The primary outcome is the rate of incisional hernia at 6 months postoperatively. Secondary outcomes include surgical site infection (SSI), wound dehiscence, chronic pain, and suture sinus formation. ■ Participants The study will include patients aged 18 to 70 years undergoing elective or emergency midline laparotomy with clean or clean-contaminated wounds (CDC Class I or II). Inclusion Criteria: Aged 18-70 years Elective or emergency laparotomy Clean or clean-contaminated wounds Ability to provide informed consent Availability for 6-month follow-up Exclusion Criteria: Contaminated or dirty wounds (CDC Class III or IV) Immunocompromised patients (e.g., on steroids, chemotherapy, HIV) Prior midline laparotomy with incisional hernia Severe malnutrition (BMI \<16 kg/m² or albumin \<2.5 g/dL) Pregnancy Requirement for temporary abdominal closure or planned reoperation ■ Interventions Polyglactin (Vicryl): A synthetic absorbable braided suture composed of glycolide and lactide copolymers. It is absorbed by hydrolysis over 56-70 days, providing temporary wound support during healing. Polypropylene (Prolene): A synthetic non-absorbable monofilament suture known for its permanent tensile strength and excellent biocompatibility, offering long-term mechanical support and minimal tissue reaction. Outcome Measures Primary Outcome: Incidence of incisional hernia at 6 months, confirmed by clinical examination and ultrasound if necessary. Secondary Outcomes: Surgical Site Infection (SSI): Defined as an infection occurring within 30 days post-surgery, classified as superficial, deep, or organ/space. Wound Dehiscence: Partial or complete disruption of the abdominal wall closure within 30 days post-surgery. Chronic Pain: Persistent pain at the surgical site lasting more than 3 months, assessed using the Visual Analog Scale (VAS). Suture Sinus Formation: Chronic draining tract related to the suture material. Statistical Analysis Data will be analyzed using SPSS version 26. Chi-square tests will compare proportions of complications between the two groups, and relative risk will be calculated with 95% confidence intervals. Stratified analysis will assess the impact of potential modifiers such as age, gender, and comorbidities (e.g., diabetes, hypertension). Potential Impact The findings from this study aim to improve surgical outcomes in Pakistan and similar settings. By identifying the more effective suture material for rectus sheath closure, this research will help guide clinical practices, reducing common complications like incisional hernia and infection. It may also contribute to better surgical standards in regions lacking high-quality comparative data.

Conditions

• Chronic Pain
• Wound Dehiscence
• Surgical Site Infection (SSI)
• Incisional Hernia
• Rectus Sheath Closure
• Abdominal Surgery

Interventions

Type	Name	Description
PROCEDURE	Polyglactin 910 (Vicryl) Suture	Polyglactin 910 (Vicryl) is an absorbable synthetic multifilament suture material used for rectus sheath closure following laparotomy. This suture material undergoes hydrolytic degradation over a period of 56-70 days and retains approximately 75% of its tensile strength at 2 weeks and 50% at 3 weeks, which aligns with the typical biological timeline for fascial healing. It is used to approximate the anterior rectus sheath with a continuous suturing technique.
PROCEDURE	Polypropylene (Prolene) Suture	Polypropylene (Prolene) is a non-absorbable monofilament suture material used for rectus sheath closure following laparotomy. It provides long-term mechanical support for abdominal wall closure and does not degrade over time. The suture material maintains its tensile strength indefinitely and is known for its high biocompatibility, minimal tissue reaction, and resistance to infection due to its monofilament structure. It is applied using a continuous suturing technique.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-30
• Completion: 2027-07-30
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

1 site across 1 country: Pakistan