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

Primary Purpose

Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cesarean section
subcutanous sutures
subcutanous drain
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

interrupted closure of subcutaneous tissue with dra

interrupted closure of subcutaneous tissue without dra

non closure of subcutaneous tissue with drain

non closure of subcutaneous tissue and no drain

Arm Description

consist of 75 patients that will be allocated for interrupted closure of subcutaneous tissue with drain

consist of 75 patients that will be allocated for interrupted closure of subcutaneous tissue without 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

75 women without subcutanous sutures and without drain

Outcomes

Primary Outcome Measures

wound infection
subjective evaluation of wound redness, seroma and induration

Secondary Outcome Measures

Full Information

First Posted
November 21, 2019
Last Updated
December 12, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04177381
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
September 11, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interrupted closure of subcutaneous tissue with dra
Arm Type
Active Comparator
Arm Description
consist of 75 patients that will be allocated for interrupted closure of subcutaneous tissue with drain
Arm Title
interrupted closure of subcutaneous tissue without dra
Arm Type
Active Comparator
Arm Description
consist of 75 patients that will be allocated for interrupted closure of subcutaneous tissue without drain
Arm Title
non closure of subcutaneous tissue with drain
Arm Type
Active Comparator
Arm Description
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
Arm Title
non closure of subcutaneous tissue and no drain
Arm Type
Active Comparator
Arm Description
75 women without subcutanous sutures and without drain
Intervention Type
Procedure
Intervention Name(s)
Cesarean section
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
subcutanous sutures
Intervention Description
suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm
Intervention Type
Device
Intervention Name(s)
subcutanous drain
Intervention Description
Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin
Primary Outcome Measure Information:
Title
wound infection
Description
subjective evaluation of wound redness, seroma and induration
Time Frame
2-8 weeks after the operation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed maged
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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