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

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

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

Study Overview

• Status: Completed
• Conditions: Wound Infection
• Intervention / Treatment: Procedure: Cesarean section; Procedure: subcutanous sutures; Device: subcutanous drain

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12111
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: non closure of subcutaneous tissue with drain; 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; 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.; Device: subcutanous drain; Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin
Active Comparator: interrupted closure of subcutaneous tissue with drain; consist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain	Procedure: Cesarean section; 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.; 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
Active Comparator: interrupted closure of subcutaneous tissue without dra; consist of 88 patients that will be allocated for interrupted closure of subcutaneous tissue without drain	Procedure: Cesarean section; 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.; Procedure: subcutanous sutures; suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm
Active Comparator: non closure of subcutaneous tissue and no drain; 87 women without subcutanous sutures and without drain	Procedure: Cesarean section; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound infection	subjective evaluation of wound redness, seroma and induration	2-8 weeks after the operation

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: ahmed maged, PROFESSOR

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): September 11, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 24, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: 171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No