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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorThe University of The West Indies

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients who are immune-compromised e.g. Known Diabetes Mellitus or HIV positive mothers

Patients who are on long term Steroid use: e.g. SLE, Rheumatoid Arthritis

Multifetal Pregnancy

Those with anemia, requiring transfusion

Trial design

Design model

Parallel

Treatments tested in this trial

  • continuous subcutaneous tissue closure

    Procedure/Surgery

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

  • Interrupted subcutaneous tissue closure

    Procedure/Surgery

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

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: continuous subcutaneous tissue closureActive comparator 1 intervention
Group B: Interrupted subcutaneous tissue closureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical Site infection

Patients will be reviewed on Day 3 post-operatively on the surgical ward. The patients will also be reviewed on Day 7. During Week 4 and Week 12 post-operatively they will be reviewed via a telephone conversation and asked specific closed answer questions regarding the incision site to assess any thought of SSI when being reviewed.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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