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

NCT05856968 | Not Yet Recruiting

• 1 other identifier: CREC-MN.0296,2021/2022
• Study Type: interventional
• Target: 266
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

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.

  12 weeks

Study Arms (2)

continuous subcutaneous tissue closure

ACTIVE COMPARATOR

continuous subcutaneous tissue closure

Procedure: continuous subcutaneous tissue closure

Interrupted subcutaneous tissue closure

ACTIVE COMPARATOR

Interrupted subcutaneous tissue closure

Procedure: Interrupted subcutaneous tissue closure

Interventions

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.

continuous subcutaneous tissue closure

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.

Interrupted subcutaneous tissue closure

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of The West Indies: lead

Related Publications (4)

• Alalfy M, Elgazzar A, Fares T, Nagy O, Ellithy A, Lasheen Y, Kamel A, Soliman M, Hassan A, Samy A, Taher AM, Ogila AI, Saad H, Salah H, Ramadan M, Nabil M, Hatem DL, Fikry M. Effect of subcutaneous tissue closure technique in cesarean section on postoperative wound complications in obese Egyptian women. J Matern Fetal Neonatal Med. 2019 Aug;32(15):2452-2459. doi: 10.1080/14767058.2018.1438399. Epub 2018 Feb 20.

  PMID: 29415592 BACKGROUND

• Lauterbach R, Ben David C, Bachar G, Justman N, Matanes E, Ginsberg Y, Vitner D, Beloosesky R, Weiner Z, Zipori Y. Continuous versus disrupted subcutaneous tissue closure in cesarean section: A retrospective cohort study. Int J Gynaecol Obstet. 2023 Jan;160(1):113-119. doi: 10.1002/ijgo.14322. Epub 2022 Jul 15.

  PMID: 35766992 BACKGROUND

• Caribbean Institute for Health Research (CAIHR) (JA) Jamaica Health and Lifestyle Survey III (2016- 2017). Available from: https://www.moh.gov.jm/wp-content/uploads/2018/09/Jamaica-Health-and-Lifestyle-Survey-III-2016-2017.pdf

  BACKGROUND

• Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.

  PMID: 28255256 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Danielle Robinson

CONTACT

876-922-0210; danrob84@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Doctors at the Victoria Jubilee hospital will perform continuous or interrupted subcutaneous tissue closure resulting in the reduction of the occurrence of surgical site infection on overweight and obese women

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05