Comparison of Vicryl Versus Prolene for Midline Rectus Sheath Closure After Elective Laparotomy

March 1, 2026 updated by: Yousaf Jan, Hayatabad Medical Complex

Comparison of Vicryl Versus Prolene Sutures in Closure of Midline Rectus Sheath Following Elective Laparotomy: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Hayatabad Medical Complex, Peshawar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 to 70 years
  • Patients undergoing elective midline laparotomy
  • Ability to provide written informed consent

Exclusion Criteria:

  • Emergency laparotomy
  • Previous abdominal mesh placement
  • Immunocompromised patients
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Vicryl (Polyglactin 910) Suture
Vicryl (polyglactin 910) is an absorbable braided synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols.
Active Comparator: Prolene Suture Group
Participants undergoing elective midline laparotomy will have rectus sheath closure performed using Prolene (polypropylene) suture material according to standard surgical technique.
Device: Prolene (Polypropylene) Suture
Prolene (polypropylene) is a non-absorbable monofilament synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Surgical Site Infection within 30 Days Post-Laparotomy
Time Frame: 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.
30 days
Incidence of Wound Dehiscence within 30 Days Post-Laparotomy
Time Frame: 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.
30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hayatabad Medical Complex

Investigators

  • Principal Investigator: Gohar Ali, MBBS, FCPS, Hayatabad Medical Complex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Frassini S, Cobianchi L, Fugazzola P, Biffl WL, Coccolini F, Damaskos D, et al. ECLAPTE: Effective Closure of LAParoTomy in Emergency-2023 World Society of Emergency Surgery guidelines for the closure of laparotomy in emergency settings. World Journal of Emergency Surgery. 2023 July 26;18(1):42.
  • Helgeland J, Tomic O, Hansen TM, Kristoffersen DT, Hassani S, Lindahl AK. Postoperative wound dehiscence after laparotomy: a useful healthcare quality indicator? A cohort study based on Norwegian hospital administrative data. BMJ Open. 2019 Apr 3;9(4):e026422.
  • Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19.
  • Akbar F, Khan M, Ahmad N, Abbas S, Khan N. Comparison of Laparotomy Wound Dehiscence (LWD) Rate Using Interrupted X-Suture Technique vs Continuous Suture Technique in Rectus Sheath in Emergency Laparotomy. Journal of Saidu Medical College Swat. 2021;11(3):133-6.
  • Usman Ali Rahman, Muhammad Adil Iftikhar, Mohammad Zia Ul Miraj, Maliha Javaid Butt, Iftikhar Ahmed, Humaira Yousaf. Incidence of wound dehischence and factors causing wound dehiscence in patients undergoing laparotomy in a newly established surgery department at a tertiary care hospital. TPMJ. 2023 Oct 5;30(10):1225-9.
  • Kunju RD, Thakkannavar V, K SM, G SH, Netto A, J S, et al. A clinical study of continuous and interrupted fascial closure in emergency midline laparotomy at a tertiary care centre. International Surgery Journal. 2017 May 24;4(6):2014-7.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

March 1, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMC-RECTUS-2019
  • HMC-QAD-F-2019 / IREB-No.1680 (Other Identifier: Ethical committe Hayatabad Medical Complex)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data, including demographics, surgical details, and postoperative outcomes, will be shared with qualified researchers for scientific research purposes only. Data will be available after publication of the primary results and provided in a secure, de-identified format upon submission of a research proposal and data use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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