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NCT03354078 Clinical Trial

Effect of Subcutaneous Tissue Closure on Wound Complications

Cesarean Section Clinical Trial

Official title:
The Effect of Subcutaneous Tissue Closure Technique in Cesarean Section on Reducing Postoperative Wound Complications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03354078
Other study ID # Cesarean section / sutures
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 18, 2017
Est. completion date November 23, 2017

Study information
Verified date April 2022
Source Aljazeera Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. In a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth >2 cm.

Description:

Postoperative wound complications are one of the great issues in cesarean section (CS) with an incidence ranging from 3% to 30%.1 Obesity, operative time, diabetes, age of the patient, anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed labor with many vaginal examinations and reduced nutrition are recognized risk factors for wound infections. Evaluating the various techniques for closure of the subcutaneous layer.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date November 23, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - All patients included in this research BMI = 30, First cesarean section performed, no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination. depth of subcutaneous tissue estimated by a special device used (sterilized operative ruler). number of sutures estimation Exclusion Criteria: - The following patients were excluded BMI <30, Previous CS, DM with pregnancy, HTN with pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• interrupted sutures
The way of closing subcutaneous tissue either by interrupted
• continous sutures
The way of closure of subcutanous tissue is by continous sutures

Locations
Country Name City State
Egypt Algazeerah Giza

Sponsors (1)
Lead Sponsor Collaborator
Aljazeera Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of participants who passed without postoperative complications Describes how many participant willnot complain from wound seroma , wound erythema and wound infection one month post cesarean section
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