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NCT Number: NCT07451990

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

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.

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Key information

Conditions

Laparotomy Closure After Abdominal Surgery Complications Wounds Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Suture Materials Wound Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Medical Complex, Peshawar

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vicryl (Polyglactin 910) Suture

Device

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.

Prolene (Polypropylene) Suture

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hayatabad Medical Complex

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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