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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04177381

Collaborator

(none)

300

Enrollment

Location

Arms

10.1

Actual Duration (Months)

29.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomised cinical trial in demmita General Hospital.300 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 3 groups (100 patients in each group)and compare the role of subcutaneous tissue closure in post cesarean section wound complications.

Condition or Disease	Intervention/Treatment	Phase
Wound Infection	Procedure: Cesarean section Procedure: subcutanous sutures Device: subcutanous drain	N/A

Detailed Description

3groups are: A- interrupted closure of subcutaneous tissue without drain. B-interrupted closure of subcutaneous tissue with drain. C-non closure of subcutaneous tissue. All womenu nder 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 was achieved using electrocautery and skin was approximated

with subcuticular suture using 2-0 polyglactin910 (VicrylRapide). In the drain group, a closed nonvacuum drain was inserted in the tissue and exited from the skin through a separate opening and stitched to the skin. The subcutaneous tissue was sutured. Cautery was used for hemostasis. 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 operativewith regard to postoperative pain, postoperative fever, hospital stay duration, wound infection, wound seroma, wound disruption, and the need for redressing. T he 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. The data of the patients who did not attend hospital for examination were collected through telephone interview

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Actual Primary Completion Date :

Sep 11, 2020

Actual Study Completion Date :

Oct 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: interrupted closure of subcutaneous tissue with dra consist of 75 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 75 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 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: non closure of subcutaneous tissue and no drain 75 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.

Outcome Measures

Primary Outcome Measures

wound infection [2-8 weeks after the operation]
subjective evaluation of wound redness, seroma and induration

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy medical school	Cairo		Egypt	12111

Sponsors and Collaborators

Cairo University

Investigators

Study Director: ahmed maged, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed M Maged, MD, professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04177381

Other Study ID Numbers:

First Posted:

Nov 26, 2019

Last Update Posted:

Dec 23, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wound Infection

Study Results

No Results Posted as of Dec 23, 2021