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Investigation of Continuous Versus Interrupted Subcutaneous Fat Closure in Reducing Surgical Site Infection

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 11, 2025 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Nov 30, 2023 to Sep 1, 2026v2 Show 4 more changesShow less
    • Start date: May 15, 2023 to Sep 1, 2025
    • Study completion date: Apr 30, 2024 to Sep 30, 2026
    • Study description revised
    • Study title shortened, about 14 words
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This research aims to clarify the best way to perform subcutaneous tissue closure in overweight and obese patients undergoing caesarean section to reduce the occurrence of surgical site infections. This Study seeks to get some local perspective on the need for and type of subcutaneous fat closure in obese women undergoing cesarean section, thereby reducing Surgical Site Infection. This is a pilot; double- blinded randomized control trial, with balanced randomization (1:1) and parallel grouped study. The sample size calculated by Raosoft Sample Size Calculator Software determined that based on a margin of error of 5%, there would need to be 266 participants to give 90% confidence level to detect a significant difference between both arms of the study. Patients who are immune-compromised, those with anemia, requiring transfusion will be excluded from the study, also any mother who wishes not to participate. Patients will be reviewed 7 days post operatively. Wound complications will be identified by a questionnaire by telephone at 4 weeks and 3 months post operatively. Data will be collected from Specific closed answer questions. Data extraction sheet will be used to collect data for the patient. This information will be collected either from the docket, direct review or examination of the study participants. The research will be done at Victoria Jubilee Hospital. The Research will last six months.
Trial Details
NCT Number NCT05856968
Lead Sponsor The University of The West Indies
Conditions
(from sponsor)
Pregnancy, Obesity
Related terms Obesity
Enrollment 266 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov