Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure (PolySuture)

December 9, 2025 updated by: Dr. Waseem Ullah, Lady Reading Hospital, Pakistan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
        • Lady Reading Hospital, Department of General Surgery

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incisional Hernia rate
Time Frame: 6 months postoperatively
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (SSI) Rate
Time Frame: 30 days post-surgery
This outcome will measure the occurrence of any surgical site infection (SSI) within 30 days postoperatively.
30 days post-surgery
Suture Sinus Formation
Time Frame: 6 months post-surgery
The occurrence of chronic draining tracts at the incision site, which are associated with the suture material.
6 months post-surgery
Chronic Pain (Visual Analog Scale, VAS ≥4)
Time Frame: 3 months post-surgery
The presence of chronic pain at the surgical site lasting more than 3 months postoperatively, assessed using the Visual Analog Scale (VAS), where the VAS is a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). A score of 4 or higher indicates the presence of clinically significant chronic pain.
3 months post-surgery
Wound Dehiscence
Time Frame: 30 days post-surgery
The occurrence of wound dehiscence, defined as partial or complete disruption of the rectus sheath, within 30 days post-surgery.
30 days post-surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lady Reading Hospital, Pakistan

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 563/LRH/MTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data (IPD) that will be shared includes de-identified demographic information, surgical details, treatment outcomes, and relevant follow-up data (e.g., wound healing, incidence of complications, pain scores, and hernia occurrence). This will provide valuable insight into the comparative efficacy of polyglactin versus polypropylene sutures for rectus sheath closure. The data will be available to qualified researchers after the primary results have been published and the study is concluded.

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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