Effect of Subcutaneous Tissue Closure on Wound Complications

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Procedure: interrupted sutures; Procedure: continous sutures

• Registration Number: NCT03354078
• Lead Sponsor: Aljazeera Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-06-18
• Primary Completion: 2017-11-01
• Study First Submitted: 2017-11-19
• Study First Submitted QC: 2017-11-21
• Study Completion: 2017-11-23
• Study First Posted: 2017-11-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interrupted sutures group	continous sutures	This group in which closure of the subcutaneous layer is closed by interrupted sutures
Continous sutures group	interrupted sutures	subcutanous tissue layer is closed by continous sutures in this group
interrupted sutures group	interrupted sutures	This group in which closure of the subcutaneous layer is closed by interrupted sutures
Continous sutures group	continous sutures	subcutanous tissue layer is closed by continous sutures in this group

Primary Outcome Measures

Name	Time	Method
The number of participants who passed without postoperative complications	one month post cesarean section	Describes how many participant willnot complain from wound seroma , wound erythema and wound infection

Trial Locations

Locations (1)

Algazeerah; 🇪🇬 Giza, Egypt