Back to resultsEvaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure
Primary Purpose
Surgical Wound Closure Technique
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
surgical wound suturing
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound Closure Technique focused on measuring surgical wound closure, subdermal wound suturing, traditional wound closure
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.
Sites / Locations
- Abouqir General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
Single layer wound closure group
Arm Description
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
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
Outcomes
Primary Outcome Measures
single layer closure is as efficient and reliable as the multi-layer closure
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05166681
First Posted
December 9, 2021
Last Updated
December 21, 2021
Sponsor
Abouqir General Hospital
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT05166681
Brief Title
Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abouqir General Hospital
Collaborators
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Closure Technique
Keywords
surgical wound closure, subdermal wound suturing, traditional wound closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Single layer wound closure group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
surgical wound suturing
Other Intervention Name(s)
single layer wound closure
Intervention Description
single layer surgical wound suturing in comparison with the traditional multi-layer wound suturing
Primary Outcome Measure Information:
Title
single layer closure is as efficient and reliable as the multi-layer closure
Description
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
Time Frame
6 months follow up post-surgical
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Abouqir General Hospital
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
data collected and results of the study will be evaluated and announced
Learn more about this trial
Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure
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