Hand InjuriesNCT05218252
Reconstruction of Hand Soft Tissue Defects
A study testing Posterior interosseous artery flap in people with Hand Injuries, run by Sohag University at 1 site in Egypt.
Trial summary
Evaluation of distally based posterior interosseous artery flap in reconstructing hand soft tissue defects that may result from trauma, extensive burns, tumor resection or congenital deformities. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Posterior interosseous artery flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2022to Dec 2022
- 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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with complex defects over the dorsal and palmar aspect of the wrist and the hand up to the proximal interphalangeal joint level, the whole thumb, and the first web space.
- Small to moderate hand defects resulting from post-traumatic raw areas, post-traumatic deformities, postburn deformities and scar, post tumor resection, and congenital hand deformity.
- Availability of a healthy donor site.
Who cannot join
- Patients with a major uncontrollable medical illness.
- Chronic heavy smokers.
- Traumatic injury to the donor site.
- Complex defects of the hand beyond the PIP joint level.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Ahmed Talaat, Demonstrator, +2001013610088, drahmed202022@gmail.com
About this study
Official title: Reliability and Versatility of Posterior Interosseous Artery Flap in Reconstructing Hand Soft Tissue Defects.
Evaluation of distally based posterior interosseous artery flap in reconstructing hand soft tissue defects that may result from trauma, extensive burns, tumor resection or congenital deformities.
- Conditions
- Hand Injuries
- Being tested
- Posterior interosseous artery flap
- Keywords
- Posterior interosseous artery flap, Hand soft tissue defects
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior interosseous artery flapProcedure or surgery
The use of distally based posterior interosseous artery flap from the forearm in reconstructing mild to moderate hand soft tissue defects
| Study group | Role | What they receive |
|---|---|---|
| Hand soft tissue defects | Other | Patients with mild to moderate hand soft tissue defects with exposed bone, tendons or cartilage resulting from trauma, tumor ablation or postburn deformities. Receives: Procedure: Posterior interosseous artery flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and aesthetic outcomes of posterior interosseous artery flap
All patients will be evaluated with objective (functional) and subjective (aesthetic) criteria. Hand functionality will be evaluated using the disability of the arm, shoulder, and hand (DASH) score. The DASH score comprises 30 questions, and the score ranges from 30 points, for no limitation, to 150 points, for maximum limitation.
The outcomes will be aesthetically reviewed with scar assessment measured as being good, fair, and poor. This assessment is subjective. Donor site problems are identified as cold intolerance, numbness, and pain. These will be evaluated as being either present in the patient or non-existent.
Measured: 5 months from the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start6 Jan 2022
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Talaat Ahmed, Sohag University
- Investigators
- Ahmed Talaat, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218252
- Sponsor's protocol ID
- Soh-Med-22-01-06
- Status last verified
- Jun 2022
- First submitted
- 17 Jan 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Versatility of Posterior Interosseous Artery Flap in Reconstructing Hand Soft Tissue Defects.
- ClinicalTrials.gov ID
- NCT05218252
- Acronym / sponsor ID
- Soh-Med-22-01-06
- Conditions
- Hand Injuries
- Keywords
- Posterior interosseous artery flap, Hand soft tissue defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Feb 2022 (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.
Evaluation of distally based posterior interosseous artery flap in reconstructing hand soft tissue defects that may result from trauma, extensive burns, tumor resection or congenital deformities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand soft tissue defects | Other | Procedure: Posterior interosseous artery flapPatients with mild to moderate hand soft tissue defects with exposed bone, tendons or cartilage resulting from trauma, tumor ablation or postburn deformities. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with complex defects over the dorsal and palmar aspect of the wrist and the hand up to the proximal interphalangeal joint level, the whole thumb, and the first web space.
- Small to moderate hand defects resulting from post-traumatic raw areas, post-traumatic deformities, postburn deformities and scar, post tumor resection, and congenital hand deformity.
- Availability of a healthy donor site.
Key exclusion criteria (4 listed)
- Patients with a major uncontrollable medical illness.
- Chronic heavy smokers.
- Traumatic injury to the donor site.
- Complex defects of the hand beyond the PIP joint level.
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 |
|---|---|---|
| Posterior interosseous artery flapThe use of distally based posterior interosseous artery flap from the forearm in reconstructing mild to moderate hand soft tissue defects | Procedure or surgery | Hand soft tissue defects |
Primary outcome
Functional and aesthetic outcomes of posterior interosseous artery flap
Time frame: 5 months from the end of treatment
All patients will be evaluated with objective (functional) and subjective (aesthetic) criteria. Hand functionality will be evaluated using the disability of the arm, shoulder, and hand (DASH) score. The DASH score comprises 30 questions, and the score ranges from 30 points, for no limitation, to 150 points, for maximum limitation. The outcomes will be aesthetically reviewed with scar assessment measured as being good, fair, and poor. This assessment is subjective. Donor site problems are identified as cold intolerance, numbness, and pain. These will be evaluated as being either present in the patient or non-existent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Ahmed Talaat principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior interosseous artery flap in people with Hand Injuries, run by Sohag 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 3 inclusion and 4 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 5 Jul 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.
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 Ahmed Talaat, Demonstrator (+2001013610088, drahmed202022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and aesthetic outcomes of posterior interosseous artery flap (time frame: 5 months from the end of treatment). 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 5 Jul 2022.