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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177381
• Other study ID #: 171
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: October 2, 2020

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Infection

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound infection	subjective evaluation of wound redness, seroma and induration	2-8 weeks after the operation