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

NCT05474677 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2022-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Suture Size, Incisional Hernia

Interventions

PROCEDURE

closure of the abdominal fascia

The abdomen will be closed in intervention group with continuous PDS 2\\0 sutures and size zero in control group.

Sponsors & Collaborators

  • Raya Al shaaibi

    lead OTHER_GOV

Principal Investigators

  • mohmmed al abri, consultant · Oman Medical Specialty Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Oman

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05474677 on ClinicalTrials.gov