Coverage of Soft Tissue DefectsNCT05718635
Perforator Mapping and Optimizing Design of the Lateral Arm Flap
A study testing coloured duplex and supra facial dissection in people with Coverage of Soft Tissue Defects, run by Aswan University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings. flap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coverage of Soft Tissue Defects
- What is being tested?
- coloured duplex and supra facial dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 30 Jun 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adult patients
Who cannot join
- children injury to pedicle
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Aswān, 81528
OSAMA ELBANNA, MD, 021067076234, osamaelbanna@aswu.edu.eg
About this study
Official title: Perforator Mapping and Optimizing Design of the Lateral Arm Flap: Clinical Trial
The goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings.
flap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection.
- Conditions
- Coverage of Soft Tissue Defects
- Being tested
- coloured duplex, supra facial dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coloured duplexDiagnostic test
colored duplex to locate numbers sites and size of perforators.
supra facial dissectionProcedure or surgery
flap raising in supra facial plane
| Study group | Role | What they receive |
|---|---|---|
| patients candidate for lateral arm flap | Experimental | Not described Receives: Diagnostic Test: coloured duplex; Procedure: supra facial dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of perforators
numbers of perforators in the flap
Measured: two years
site of perforators
distance from lateral humeral epicondyle in CM
Measured: two years
Size of perforators
size in millimeter
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Oct 2020
- Primary completion26 Mar 2023
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coverage of Soft Tissue DefectsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Hassan Elbanna, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718635
- Sponsor's protocol ID
- AswanU
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforator Mapping and Optimizing Design of the Lateral Arm Flap: Clinical Trial
- ClinicalTrials.gov ID
- NCT05718635
- Acronym / sponsor ID
- AswanU
- Conditions
- Coverage of Soft Tissue Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Feb 2023 (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 goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings.
flap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients candidate for lateral arm flap | Experimental | Diagnostic Test: coloured duplex, Procedure: supra facial dissection |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients
Key exclusion criteria (1 listed)
- children injury to pedicle
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 |
|---|---|---|
| coloured duplexcolored duplex to locate numbers sites and size of perforators. | Diagnostic test | patients candidate for lateral arm flap |
| supra facial dissectionflap raising in supra facial plane | Procedure or surgery | patients candidate for lateral arm flap |
Primary outcome
numbers of perforators
Time frame: two years
numbers of perforators in the flap
site of perforators
Time frame: two years
distance from lateral humeral epicondyle in CM
Size of perforators
Time frame: two years
size in millimeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Coverage of Soft Tissue Defects
RecruitingPhase 4
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Soft Tissue Defects, Soft Tissue Wounds
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coloured duplex and supra facial dissection in people with Coverage of Soft Tissue Defects, run by Aswan University 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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OSAMA ELBANNA, MD. (021067076234, osamaelbanna@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of perforators (time frame: two years). The study lists 3 primary outcomes in all. 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 28 Mar 2023.