Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure

NCT07280975 | Not Yet Recruiting

• 1 other identifier: 563/LRH/MTI
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Polyglactin Sutures; Polypropylene Sutures; Non-Absorbable Sutures; Postoperative Complications; Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

• Incisional Hernia rate

  The primary outcome will assess the rate of incisional hernia at 6 months post-surgery in patients who undergo rectus sheath closure with either Polyglactin 910 (Vicryl) or Polypropylene (Prolene) sutures.

  6 months postoperatively

Secondary Outcomes (4)

• Surgical Site Infection (SSI) Rate

  30 days post-surgery

• Suture Sinus Formation

  6 months post-surgery

• Chronic Pain (Visual Analog Scale, VAS ≥4)

  3 months post-surgery

• Wound Dehiscence

  30 days post-surgery

Study Arms (2)

Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure

EXPERIMENTAL

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

Procedure: Polyglactin 910 (Vicryl) Suture

Polypropylene (Prolene) Suture for Rectus Sheath Closure

ACTIVE COMPARATOR

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.

Procedure: Polypropylene (Prolene) Suture

Interventions

Polyglactin 910 (Vicryl) Suture 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.

Polyglactin 910 (Vicryl) Suture for Rectus Sheath Closure

Polypropylene (Prolene) Suture 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.

Polypropylene (Prolene) Suture for Rectus Sheath Closure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years.
• Type of Surgery: Patients undergoing elective or emergency midline laparotomy.
• Wound Classification: Clean or clean-contaminated wounds (CDC Class I or II).
• Ability to Provide Informed Consent: Participants must be able to understand and sign the informed consent form.
• Availability for Follow-Up: Participants must be available for 6 months follow-up.

You may not qualify if:

• Contaminated or Dirty Wounds: Patients with CDC Class III or IV wounds.
• Immunocompromised Conditions: Patients on steroids, chemotherapy, or those with HIV.
• Previous Midline Laparotomy with Incisional Hernia: Patients who have a history of incisional hernia after midline laparotomy.
• Severe Malnutrition: Patients with BMI \< 16 kg/m² or albumin \< 2.5 g/dL.
• Emergency Laparotomy with Hemodynamic Instability: Patients who are unstable or in a critical condition.
• Pregnancy: Pregnant women.
• Need for Temporary Abdominal Closure or Planned Reoperation: Patients requiring staged reoperation or temporary closure.

Sponsors & Collaborators

• Lady Reading Hospital, Pakistan: lead

Study Sites (1)

Lady Reading Hospital, Department of General Surgery

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Chronic Pain; Surgical Wound Infection; Incisional Hernia; Postoperative Complications

Interventions

Polyglactin 910; Sutures; Polypropylenes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections; Pathologic Processes; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Plastics

Central Study Contacts

Dr. Atta Ullah Arif Associate Professor, MBBS, FCPS

CONTACT

+92 333 9126978; attaullah.arif@Irh.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is single-blind, meaning the participants do not know which suture material they received. The outcomes assessor (surgeon) will also be blinded to the group allocation to reduce bias in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar, General Surgery

Model Details: This is a parallel-group design, where participants are assigned to one of two treatment arms (polyglactin or polypropylene). Both arms will undergo the same procedure but with different suture materials for rectus sheath closure.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 15, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting information will be accessible to qualified researchers affiliated with academic, medical, or research institutions who are involved in the study of similar surgical outcomes or suture materials. These researchers will be able to access: De-identified patient data (demographic, clinical outcomes, complications) Study protocol, SAP, ICF, CSR, and analytic code
• Access Criteria: Access will be granted through a secure online platform (such as a data repository) after a formal request and approval by the institution's data access committee. Researchers will be required to adhere to confidentiality agreements and data protection regulations.

Locations

PA (1)