Surgical Wound Closure TechniquePhase 3NCT05166681
Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure
A Phase 3 study testing surgical wound suturing in people with Surgical Wound Closure Technique, run by Abouqir General Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Closure Technique
- What is being tested?
- surgical wound suturing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 5 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Surgical Wound Closure Technique
- Being tested
- surgical wound suturing
- Keywords
- surgical wound closure, subdermal wound suturing, traditional wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical wound suturingProcedure or surgery
Also called single layer wound closure
single layer surgical wound suturing in comparison with the traditional multi-layer wound suturing
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 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 Receives: Procedure: surgical wound suturing |
| Single layer wound closure group | Experimental | 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 Receives: Procedure: surgical wound suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months follow up post-surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Sep 2020
- Primary completion5 Dec 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound Closure TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abouqir General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Ahmed Mohamed Abouzaid, Abouqir General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166681
- Sponsor's protocol ID
- 0304744
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data collected and results of the study will be evaluated and announced
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05166681
- Acronym / sponsor ID
- 0304744
- Conditions
- Surgical Wound Closure Technique
- Keywords
- surgical wound closure, subdermal wound suturing, traditional wound closure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abouqir General HospitalUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: surgical wound suturingcases 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 |
| Single layer wound closure group | Experimental | Procedure: surgical wound suturingcases 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 |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical wound suturingAlso: single layer wound closuresingle layer surgical wound suturing in comparison with the traditional multi-layer wound suturing | Procedure or surgery | Single layer wound closure group, control group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided. data collected and results of the study will be evaluated and announced
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing surgical wound suturing in people with Surgical Wound Closure Technique, run by Abouqir General Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single layer closure is as efficient and reliable as the multi-layer closure (time frame: 6 months follow up post-surgical). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.