Health Trials

Skin Staples vs Polypropylene in Elective Laparotomy

ConditionSurgical Site Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-50
SponsorPakistan Institute of Medical Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Skin StaplesExperimental treatment 1 intervention
Group B: Poly propylene suturesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical site infection

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

Time frame
30 days

Secondary outcomes

1

Skin closure time

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

Time frame
During the surgery
2

Wound Dehiscence

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

Time frame
30 days
3

Post-operative pain

Pain scored on verbal descriptor scale from 1 to 10

Time frame
7 days
4

Scar appearance

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

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Institute of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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