Tendon Injury - HandNCT07074223
Deep Fascial Graft Versus Acellular Dermal Matrix Conduit on Repaired Hand's Flexor Tendon: A Comparative Study
A study testing Fascial wrapping the site of tendon repair, Modified Kestler tendon repair and ADM (Pelnac) wrapping of repaired tendon in people with Tendon Injury - Hand, run by Aswan University at 1 site in Egypt.
Trial summary
The investigators aim to evaluate the efficacy \& applicability of using deep fascial grafts and acellular dermal matrix conduits in reducing post flexor tendon repair adhesions and improving the clinical outcome. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tendon Injury - Hand
- What is being tested?
- Fascial wrapping the site of tendon repair, Modified Kestler tendon repair and ADM (Pelnac) wrapping of repaired tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 Jun 2024
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- recent hand cut tendon
Who cannot join
- All patients less than 16 years old.
- Zone 1 , 3 , 4 and zone 5 flexor tendon injuries.
- Patients with flexor pollicis longus tendon injury.
- Severely lacerated or crushed tendons.
- Tendon defects.
- Multiple level tendon injuries.
Show all 11Show fewer
- Associated injuries to muscles.
- Associated hand or forearm fractures.
- Patients with poor general condition.
- Patients with limited passive hand movements.
- Soft tissues defects overlying the repaired tendons.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to evaluate the efficacy \& applicability of using deep fascial grafts and acellular dermal matrix conduits in reducing post flexor tendon repair adhesions and improving the clinical outcome.
- Conditions
- Tendon Injury - Hand
- Being tested
- Fascial wrapping the site of tendon repair, Modified Kestler tendon repair, ADM (Pelnac) wrapping of repaired tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial wrapping the site of tendon repairProcedure or surgery
wrapping the tendon repair site by Pelnac or Fascial graft
Modified Kestler tendon repairProcedure or surgery
Modified Kestler tendon repair
ADM (Pelnac) wrapping of repaired tendonProcedure or surgery
Modifed kestler tendon repair wrapped by ADM ( Pelnac)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Modefied kestler tendon repair Receives: Procedure: Modified Kestler tendon repair |
| Pelnac Group | Experimental | Modified kestler tendon repair wrapped by Pelnac Receives: Procedure: ADM (Pelnac) wrapping of repaired tendon |
| Fascia Group | Experimental | modefied kestler tendon repair wrapped by fascial graft Receives: Procedure: Fascial wrapping the site of tendon repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant with treatment related limitation of Movement
Buck-Gramcko II criteria
Measured: 6 months postoperative
Number of participant who have fibrous adhesions in Ultra sonography
muscloskeletal ultrasonography
Measured: 6 months poostoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 May 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon Injury - HandStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT07074223
- Sponsor's protocol ID
- Tendon fascial graft
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Fascial Graft Versus Acellular Dermal Matrix Conduit on Repaired Hand's Flexor Tendon: A Comparative Study
- ClinicalTrials.gov ID
- NCT07074223
- Acronym / sponsor ID
- Tendon fascial graft
- Conditions
- Tendon Injury - Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Jul 2025 (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 investigators aim to evaluate the efficacy \& applicability of using deep fascial grafts and acellular dermal matrix conduits in reducing post flexor tendon repair adhesions and improving the clinical outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Procedure: Modified Kestler tendon repairModefied kestler tendon repair |
| Pelnac Group | Experimental | Procedure: ADM (Pelnac) wrapping of repaired tendonModified kestler tendon repair wrapped by Pelnac |
| Fascia Group | Experimental | Procedure: Fascial wrapping the site of tendon repairmodefied kestler tendon repair wrapped by fascial graft |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- recent hand cut tendon
Key exclusion criteria (11 listed)
- All patients less than 16 years old.
- Zone 1 , 3 , 4 and zone 5 flexor tendon injuries.
- Patients with flexor pollicis longus tendon injury.
- Severely lacerated or crushed tendons.
- Tendon defects.
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 |
|---|---|---|
| Fascial wrapping the site of tendon repairwrapping the tendon repair site by Pelnac or Fascial graft | Procedure or surgery | Fascia Group |
| Modified Kestler tendon repairModified Kestler tendon repair | Procedure or surgery | Control Group |
| ADM (Pelnac) wrapping of repaired tendonModifed kestler tendon repair wrapped by ADM ( Pelnac) | Procedure or surgery | Pelnac Group |
Primary outcome
Number of participant with treatment related limitation of Movement
Time frame: 6 months postoperative
Buck-Gramcko II criteria
Number of participant who have fibrous adhesions in Ultra sonography
Time frame: 6 months poostoperative
muscloskeletal ultrasonography
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 20 Jul 2025.
- 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.
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 study testing Fascial wrapping the site of tendon repair, Modified Kestler tendon repair and ADM (Pelnac) wrapping of repaired tendon in people with Tendon Injury - Hand, 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 11 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 20 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
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?
Number of participant with treatment related limitation of Movement (time frame: 6 months postoperative). The study lists 2 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 20 Jul 2025.