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Skin Staples vs Polypropylene in Elective Laparotomy

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fields
  2. Eligibility criteria shortened, about 2 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07781878
Lead Sponsor Pakistan Institute of Medical Sciences
Conditions
(from sponsor)		 Surgical Site Infection
Related terms Infections, Surgical Wound Infection
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov