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NCT Number: NCT07781878

Skin Staples vs Polypropylene in Elective Laparotomy

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Institute of Medical Sciences

Islamabad, Capital, Pakistan

Location status: Recruiting

Location contact

Fahad Ali, Mbbs, mrcs

CONTACT

[email protected]

03320601136

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Skin staples

Device

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.

Polypropylene skin suture

Device

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).

Primary outcomes

  1. Surgical site infection

    Time frame: 30 days

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

Secondary outcomes

  1. Skin closure time

    Time frame: During the surgery

    Measured in seconds from the first skin puncture until completion of skin closure.

  2. Wound Dehiscence

    Time frame: 30 days

    Giving way of the skin closure leading to exposure of subcutaneous tissues.

  3. Post-operative pain

    Time frame: 7 days

    Pain scored on verbal descriptor scale from 1 to 10

  4. Scar appearance

    Time frame: 6 weeks

    Visual description of scar on analogue scsle by subjective assessment(1-10)

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Skin Staples Versus Polypropylene for Skin Closure in Elective Laparotomy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 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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