NCT05856968Not yet recruiting
Investigation of Continuous Versus Interrupted Subcutaneous Fat Closure in Reducing Surgical Site Infection
To Investigate the Effect of Continuous Versus Interrupted Subcutaneous Fat Closure in Reducing Surgical Site Infection Among Over-weight or Obese Women Who Are Undergoing Elective Caesarean Section
Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 266 (estimated)
- First submitted
- 3 May 2023
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- The University of The West Indies
- Diseases
- Obesity
- NCT number
- NCT05856968
What you commit to
- Study type: Interventional
- Planned participants: 266
- From 1 Sept 2025 to the primary completion date, 1 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are on long term Steroid use: e.g. SLE, Rheumatoid Arthritis
Other illness
- Patients who are immune-compromised e.g. Known Diabetes Mellitus or HIV positive mothers
Other
- Multifetal Pregnancy
- Those with anemia, requiring transfusion
- Obstetric Complications: e.g. Placenta Previa
- Any mother who wishes not to participate in the study
Who the study is looking for
- Overweight/Obese Women \> 25kg/m2, measured in the first trimester
- Single Fetus
- Gestational Age (37-41) week calculated by sure dates and confirmed by first trimester ultrasound
- Elective Lower Segment Cesarean Section
Sex: Female · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.