NCT07781878

Brief Summary

Surgical site infection (SSI) is one of the most common postoperative complications following elective laparotomy and contributes significantly to patient morbidity, prolonged hospital stay, and increased healthcare costs. Various techniques are available for skin closure, including skin staples and polypropylene sutures; however, evidence regarding their comparative effectiveness remains inconsistent, particularly in low- and middle-income countries. This randomized controlled trial aims to compare skin staples with polypropylene sutures for skin closure following elective laparotomy. Eligible adult patients undergoing elective laparotomy at the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), Islamabad, will be randomly allocated in a 1:1 ratio to receive either skin staples or polypropylene sutures. The primary outcomes are skin closure time and incidence of surgical site infection within 30 days of surgery. Secondary outcomes include wound dehiscence, postoperative pain, cosmetic scar appearance, patient satisfaction, and duration of hospital stay. The findings will provide evidence regarding the optimal skin closure technique for elective laparotomy in the Pakistani population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress64%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 31, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

July 26, 2026

Last Update Submit

August 19, 2026

Conditions

Surgical Site Infection

Keywords

InfectionSSISSIsLaparatomyProlene sutureStaplesWound DehiscenceGeneral surgery

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    SSI occurring within 30 postoperative days based on CDC clinical criteria with wound culture where indicated.

    30 days

Secondary Outcomes (4)

  • Skin closure time

    During the surgery

  • Wound Dehiscence

    30 days

  • Post-operative pain

    7 days

  • Scar appearance

    6 weeks

Study Arms (2)

Skin Staples

EXPERIMENTAL

Skin closure performed using disposable stainless steel skin staples.

Device: Skin staples

Poly propylene sutures

ACTIVE COMPARATOR

Skin closure performed using interrupted polypropylene (Prolene) sutures.

Device: Polypropylene skin suture

Interventions

Skin staplesDEVICE

Disposable stainless steel skin staples will be used for skin closure following elective laparotomy. Skin closure will be performed according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), immediately after completion of fascial closure.

Skin Staples
Polypropylene skin sutureDEVICE

Skin closure will be performed using interrupted polypropylene (Prolene) sutures following elective laparotomy according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS).

Poly propylene sutures

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15-50 years Elective laparotomy ASA I-III Written informed consent Male or female

You may not qualify if:

  • Emergency surgery Previous SSI Recurrent surgery BMI \<18 or \>30 kg/m² Haemoglobin \<10 g/dL COPD Stroke Renal failure Liver disease Haematological disorders Malignancy Immunocompromised state Active infection Previous chemotherapy Previous radiotherapy Malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Capital, Pakistan

RECRUITING

MeSH Terms

Conditions

Surgical Wound InfectionInfections

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Muhammad Fahad Ali

Study Record Dates

First Submitted

July 26, 2026

First Posted

August 24, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations

PA(1)