Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT05856968

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexFemale

Healthy volunteersAccepted

ConditionPregnancy, Obesity

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Obstetric Complications: e.g. Placenta Previa * Any mother who wishes not to participate in the study

Treatments and study arms

continuous subcutaneous tissue closure

Procedure

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

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

Primary outcomes

Surgical Site infection12 weeks

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.

Study locations

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No public site location was included in this record. Check the original registry for updates.