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

NCT05856968 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2025-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy, Obesity

Interventions

PROCEDURE

continuous subcutaneous tissue closure

The use of continuous subcutaneous tissue closure to determine which closure results in a lower rate of surgical site infection.

PROCEDURE

Interrupted subcutaneous tissue closure

The use of interrupted subcutaneous tissue closure to determine which closure results in a lower rate of surgical site infection.

Sponsors & Collaborators

  • The University of The West Indies

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2026-09-30

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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 NCT05856968 on ClinicalTrials.gov