NCT07451990

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

January 8, 2026

Last Update Submit

March 1, 2026

Conditions

Laparotomy Closure After Abdominal SurgerySuture MaterialsComplications Wounds

Keywords

ProleneVicrylLaparotomyWound DehiscenceSurgical site infection

Outcome Measures

Primary Outcomes (2)

  • Incidence of Surgical Site Infection within 30 Days Post-Laparotomy

    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

    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

Study Arms (2)

Vicryl Suture Group

EXPERIMENTAL

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

Prolene Suture Group

ACTIVE COMPARATOR

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

Interventions

Vicryl (Polyglactin 910) SutureDEVICE

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.

Vicryl Suture Group
Prolene (Polypropylene) SutureDEVICE

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.

Prolene Suture Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayatabad Medical Complex, Peshawar

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (6)

  • 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.

    BACKGROUND

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Gohar Ali, MBBS, FCPS

    Hayatabad Medical Complex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study as the operating surgeon is aware of the suture material used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants undergoing elective midline laparotomy are assigned to one of two parallel groups based on the type of suture material used for rectus sheath closure.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 8, 2026

First Posted

March 5, 2026

Study Start

April 1, 2024

Primary Completion

October 30, 2025

Study Completion

November 30, 2025

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

PA(1)