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Completed

NCT Number: NCT04177381

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

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

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Key information

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy medical school

Cairo, 12111, Egypt

About this study

Randomised cinical trial in Kasr Alainy Hospital.352 obese women pregnant with gestational age >38 wk ,their age range from (25-35) years and BMI between (30 -40) undergoing elective cesarean section were randomised into 3 groups (100 patients in each group)and compare the role of subcutaneous tissue closure in post cesarean section wound complications.

4 groups are:: A -interrupted closure of subcutaneous tissue with drain ( a closed nonvacuum drain was inserted in the tissue and exit 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 women under going CS with Pfannenstiel incision were considered to be eligible if time allowed informed consent before the surgery All surgical procedures were performed by obstetric and gynecology residents under the supervision of attending physicians After the sequential closure of the uterus and peritoneum, the fascia was closed with 2-0 polyglactin 910 (Vicryl). The depth of the subcutaneous adipose tissue was measured with a sterile ruler from the fascia to the skin edge at the middle of the superior aspect of the skin incision.Women with a subcutaneous tissue thickness of 4.0 cm or more were then formally enrolled and randomized to one of the two subcutaneous closure techniques. Subcutaneous hemostasis were achieved using electrocautery and skin was approximated with subcuticular suture using 2-0 polyglactin910 (VicrylRapide).company city country In the drain group, a closed nonvacuum drain was inserted in the tissue and exite from the skin through a separate opening and stitch to the skin (Al Allair 2000). company city country The drain was left until the drainage rate was less than 30 ml/day or after 72h .( The skin was closed with a continuous nonabsorbable polypropylene 2/0 (Acufirm; Ernst Kratz, Germany) subcuticular sutures. Operative time was estimated from the start of skin incision until the end of skin suturing. The drain was left until the drainage rate was less than 50 ml/day.

All randomized women received standard postoperative wound care. Surgical dressing was removed on the first postoperative and all participants were discharged 24 h after the CS. The participants were invited to two follow-up in the first and second week post operative with regard to postoperative pain, postoperative fever, hospital stay duration, wound infection, wound seroma, wound disruption, and the need for redressing. The postoperative pain was judged after 24 h using visual analogue scale, in addition any time clinically indicated. Patients and physicians who assessed the incision postoperatively were blinded towards the study group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

cesarean section

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

subcutanous sutures

Procedure

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

subcutanous drain

Device

Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin

Primary outcomes

  1. wound infection

    Time frame: 2-8 weeks after the operation

    subjective evaluation of wound redness, seroma and induration

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2019
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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