Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section
NCT ID: NCT04177381
Last Updated: 2025-06-25
Study Results
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Basic Information
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COMPLETED
NA
352 participants
INTERVENTIONAL
2021-03-04
2022-11-02
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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interrupted closure of subcutaneous tissue with drain
consist of 89 patients that will be allocated for interrupted closure of subcutaneous tissue with drain
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.
subcutanous sutures
suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm
subcutanous drain
Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin
interrupted closure of subcutaneous tissue without dra
consist of 88 patients that will be allocated for interrupted closure of subcutaneous tissue without drain
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.
subcutanous sutures
suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm
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
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.
subcutanous drain
Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin
non closure of subcutaneous tissue and no drain
87 women without subcutanous sutures and without drain
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.
Interventions
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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.
subcutanous sutures
suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm
subcutanous drain
Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin
Eligibility Criteria
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Inclusion Criteria
* Gestational age (37-41) week calculated by sure dates and confirmed by first trimester US,
* single fetus.
* Elective lower segment cesarean section
Exclusion Criteria
* 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
25 Years
35 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed M Maged, MD
professor
Principal Investigators
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ahmed maged
Role: STUDY_DIRECTOR
professor
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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References
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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.
Other Identifiers
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171
Identifier Type: -
Identifier Source: org_study_id
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