Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure

NCT ID: NCT07280975

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2027-07-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure

In this arm, participants will undergo rectus sheath closure using polyglactin 910 (Vicryl), a synthetic absorbable braided suture. This material is designed to provide temporary wound support during the healing process, with predictable hydrolytic degradation over 56-70 days. The intervention involves continuous suturing of the rectus sheath, with the suture size being 1 (USP). The primary aim is to evaluate postoperative outcomes such as incisional hernia, surgical site infections, wound dehiscence, and chronic pain, using polyglactin sutures for abdominal wall closure.Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure

Group Type: EXPERIMENTAL

Polyglactin 910 (Vicryl) Suture

Intervention Type: PROCEDURE

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.

Polypropylene (Prolene) Suture for Rectus Sheath Closure

In this arm, participants will undergo rectus sheath closure using polypropylene (Prolene), a non-absorbable monofilament suture. Polypropylene is known for its high tensile strength and biocompatibility, providing long-term mechanical support without being absorbed by the body. The intervention will involve continuous suturing of the rectus sheath, using a size 1 (USP) suture. The main focus will be to assess the incidence of complications such as incisional hernia, surgical site infection, wound dehiscence, and chronic pain following closure with polypropylene sutures.

Group Type: ACTIVE_COMPARATOR

Polypropylene (Prolene) Suture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age: 18-70 years.

2. Type of Surgery: Patients undergoing elective or emergency midline laparotomy.

3. Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).

4. Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.

5. Availability for Follow-Up: Participants must be available for 6 months follow-up.

Exclusion Criteria

1. Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.

2. Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.

3. Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.

4. Severe Malnutrition: Patients with BMI < 16 kg/m² or albumin < 2.5 g/dL.

5. Emergency Laparotomy with Hemodynamic Instability: Patients who are unstable or in a critical condition.

6. Pregnancy: Pregnant women.

7. Need for Temporary Abdominal Closure or Planned Reoperation: Patients requiring staged reoperation or temporary closure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Reading Hospital, Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Waseem Ullah

Registrar, General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lady Reading Hospital, Department of General Surgery

Peshawar, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

Central Contacts

Dr. Atta Ullah Arif Associate Professor, MBBS, FCPS

Role: CONTACT

attaullah.arif@Irh.edu.pk

+92 333 9126978

Other Identifiers

563/LRH/MTI

Identifier Type: -

Identifier Source: org_study_id