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Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section

NCT04177381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-06-25

No results posted yet for this study

Summary

Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age \>38 wk ,theire age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 4 groups and compare the role of subcutaneous tissue closure in post cesarean section wound complications.

groups are: 4 groups each group was 86 women : A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin) .

B-interrupted closure of subcutaneous tissue without drain. c- non closure of subcutaneous tissue with drain only. d- non closure of subcutaneous tissue without drain.

All womenu nder going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery

Conditions

  • Wound Infection

Interventions

PROCEDURE

Cesarean section

1. Abdominal Incision: Pfannenstiel incision Sharp dissection will be continued through the subcutaneous layer to the fascia. 2. The fascia will be then incised sharply at the midline 3. The transversalis fascia and pre peritoneal fat will be dissected carefully 4. The peritoneum will be then incised. 5. Low Transverse Cesarean Incision. Bladder flap creation effectively moves the bladder away from the planned hysterotomy site 6. Delivery of the Fetus and placenta. 7. Uterine Repair in two layers of continuous 0-or No.1 absorbable suture.

PROCEDURE

subcutanous sutures

suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm

DEVICE

subcutanous drain

Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • ahmed maged · professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2022-09-11
Completion
2022-11-02

Countries

  • Egypt

Study Locations

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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 NCT04177381 on ClinicalTrials.gov