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NCT05474677

The Suture Size in Laparotomy Wound Closure to Prevent Post-operative Complications

Status unknown NA Last updated 3 August 2022
What this trial tests

NA trial testing closure of the abdominal fascia in Suture Size, Incisional Hernia in 276 participants. Status unknown.

Timeline
1 August 2022
Primary endpoint
1 January 2025
1 January 2025

Quick facts

Lead sponsorRaya Al shaaibi
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment276
Start date1 August 2022
Primary completion1 January 2025
Estimated completion1 January 2025
Sites1 location across Oman

Drugs / interventions tested

Conditions studied

Sponsor

Raya Al shaaibi

Who can join

Adults 18 to 80, any sex, with Suture Size, Incisional Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Incisional hernia is a common complication of midline laparotomy, and it is associated with high morbidity and high costs. Suture size used in the closure of the abdominal wall fascia was not studied independently. Objective: Identify the best suture size for closure of the fascia following laparotomy incisions, by assessing the suture size 2\\0 versus zero. Research methods: Prospective, multicentric, randomized controlled and double-blind trial. Patients undergoing elective or emergency laparotomy in Royal Hospital, Sultan Qaboos University Hospital and Armed Force Hospital between 2022 and 2023. We aimed for a total of 276 patients (n=138 per group). The abdomen will be closed in intervention group with continuous PDS 2\\0 sutures and size zero in control group. Patients will be followed for immediate post-operative wound complications and late complication after 6 months then after one year.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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