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Clinical Trials/NCT05166681
NCT05166681
Completed
Phase 3

Evaluation of Surgical Wound Closure With Single Subcutaneous and Subdermal Sutures as a Single Layer in Comparison With Traditional Multiple Layer Closure in Plastic Surgery Procedures: A Randomized Controlled Trial

Abouqir General Hospital1 site in 1 country200 target enrollmentSeptember 1, 2020

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Surgical Wound Closure Technique
Sponsor
Abouqir General Hospital
Enrollment
200
Locations
1
Primary Endpoint
single layer closure is as efficient and reliable as the multi-layer closure
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

the study is comparing the results of aesthetic surgery wound closure by a single layer versus the traditional multi-layer closure as regards the wound healing time, local wound complications, and the scar formed.

Detailed Description

The study puts in comparison the surgical wound closure of aesthetic procedures by single layer sutures technique, involving part of the subcutaneous tissue and the subdermal layer, with the multi-layer traditional closure, which involves subcutaneous layer closure by one or two raws of sutures and skin closure with any type of suturing techniques, then to evaluate the wound healing time, local wound complications, and the scar formed.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 5, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Abouqir General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Abouzaid

Dr. Ahmed Mohamed Abouzaid

Abouqir General Hospital

Eligibility Criteria

Inclusion Criteria

  • all cases presented for different aesthetic surgery procedures e.g different breast contouring procedures, surgical trunk contouring procedures, Brachioplasty, and thigh lifting. No gender discrimination, age between 16-60 years.

Exclusion Criteria

  • we excluded cases in age groups beyond that designed for the study, patients with co-morbid conditions that may affect the results of wound healing e.g Diabetics. Active smokers, trauma patients, or patients that will undergo primary or secondary reconstructive procedures.

Outcomes

Primary Outcomes

single layer closure is as efficient and reliable as the multi-layer closure

Time Frame: 6 months follow up post-surgical

single layer surgical wound closure is a reliable and efficient method as the traditional multi-layer closure technique giving the same results and have the same complication rate as the traditional suturing techniques

Study Sites (1)

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