Clinical trial NCT04177381: Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section
Official title: Comparative Study Between Subcutaneous Tissue Closure Versus Drain in Obese Women Undergo Elective Cesarean Section Arandomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 352
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomised cinical trial in demmita General 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

Detailed description: Randomised cinical trial in demmita General 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.

Eligibility criteria: 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

Primary outcomes:
measure: wound infection
timeFrame: 2-8 weeks after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: ahmed maged
role: STUDY_DIRECTOR
References: