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

NCT04177381 | Completed DMC

• 1 other identifier: 171
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• wound infection

  subjective evaluation of wound redness, seroma and induration

  2-8 weeks after the operation

Study Arms (4)

interrupted closure of subcutaneous tissue with drain

ACTIVE COMPARATOR

consist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain

Procedure: Cesarean section; Procedure: subcutanous sutures; Device: subcutanous drain

interrupted closure of subcutaneous tissue without dra

ACTIVE COMPARATOR

consist of 88 patients that will be allocated for interrupted closure of subcutaneous tissue without drain

Procedure: Cesarean section; Procedure: subcutanous sutures

non closure of subcutaneous tissue with drain

ACTIVE COMPARATOR

In the drain group,a closed non vacuum drain will be inserted in the tissue and exit from the skin through a separate opening and stitch to the skin

Procedure: Cesarean section; Device: subcutanous drain

non closure of subcutaneous tissue and no drain

ACTIVE COMPARATOR

87 women without subcutanous sutures and without drain

Procedure: Cesarean section

Interventions

Cesarean section PROCEDURE

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.

interrupted closure of subcutaneous tissue with drain; interrupted closure of subcutaneous tissue without dra; non closure of subcutaneous tissue and no drain; non closure of subcutaneous tissue with drain

subcutanous sutures PROCEDURE

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

interrupted closure of subcutaneous tissue with drain; interrupted closure of subcutaneous tissue without dra

subcutanous drain DEVICE

Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin

interrupted closure of subcutaneous tissue with drain; non closure of subcutaneous tissue with drain

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• obese women who BMI(30- 40 kg/m2)
• Gestational age (37-41) week calculated by sure dates and confirmed by first trimester US,
• single fetus.
• Elective lower segment cesarean section

You may not qualify if:

• Any medical disorders affect wound healing as:
• Diabetes mellitus.
• On steroids.
• Immunedeficiency.
• Hypoalbuminemia.
• Skin infections or history of wound infections.
• Multifetal pregnancy.
• Obstetric complications eg.placenta previa.
• Anemia.
• Intraoperative complications as intestinal injury or bladder injury

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Related Publications (1)

• Shalaby MA, Metwally HHM, Maged AM, Bayoumi YA, Salah N. The value of subcutaneous tissue closure and drain in obese women undergo elective caesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 May 5;25(1):534. doi: 10.1186/s12884-025-07579-z.

  PMID: 40325365 DERIVED

MeSH Terms

Conditions

Wound Infection

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• ahmed maged

  professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 26, 2019
• Study Start: March 4, 2021
• Primary Completion: September 11, 2022
• Study Completion: November 2, 2022
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)