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Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure

Sponsor
Abouqir General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05166681
Collaborator
Alexandria University (Other)
200
Enrollment
1
Location
2
Arms
15.1
Actual Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgical wound suturing
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Dec 5, 2021
Actual Study Completion Date :
Dec 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

cases allocated to that arm are those cases having their surgical wound closure by the traditional techniques involving subcutaneous layer closure as one or more raws of sutures and then skin layer closure

Procedure: surgical wound suturing
single layer surgical wound suturing in comparison with the traditional multi-layer wound suturing
Other Names:
  • single layer wound closure

    		•
    Experimental: Single layer wound closure group

    cases allocated to that group are those having their surgical wound closure with the new technique involving part of the subcutaneous layer and the subdermal layer

    Procedure: surgical wound suturing
    single layer surgical wound suturing in comparison with the traditional multi-layer wound suturing
    Other Names:
  • single layer wound closure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. single layer closure is as efficient and reliable as the multi-layer closure [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abouqir General Hospital Alexandria Egypt 21527

    Sponsors and Collaborators

    • Abouqir General Hospital
    • Alexandria University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed Abouzaid, Dr. Ahmed Mohamed Abouzaid, Abouqir General Hospital
    ClinicalTrials.gov Identifier:
    NCT05166681
    Other Study ID Numbers:
    • 0304744
    First Posted:
    Dec 22, 2021
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Mohamed Abouzaid, Dr. Ahmed Mohamed Abouzaid, Abouqir General Hospital
    surgical wound closure
    subdermal wound suturing
    traditional wound closure
    Additional relevant MeSH terms:
    Wounds and Injuries
    Surgical Wound

    Study Results

    No Results Posted as of Jan 11, 2022