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

Wound Infection Clinical Trial

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

Status Completed

Clinical Trial 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.

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

Clinical Trial Description

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.

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 ;

Related Conditions & MeSH terms

• Wound Infection

• NCT number: NCT04177381
• Study type: Interventional
• Source: Cairo University
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Completion date: October 2, 2020