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Deep Fascial Graft Versus Acellular Dermal Matrix Conduit on Repaired Hand's Flexor Tendon: A Comparative Study

Deep Fascial Graft Versus Acellular Dermal Matrix Conduit on Repaired Hand's Flexor Tendon: A Comparative Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07074223
Enrollment
30
Registered
2025-07-20
Start date
2023-05-01
Completion date
2024-06-30
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon Injury - Hand

Brief 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.

Interventions

PROCEDUREFascial wrapping the site of tendon repair

wrapping the tendon repair site by Pelnac or Fascial graft

PROCEDUREModified Kestler tendon repair

Modified Kestler tendon repair

PROCEDUREADM (Pelnac) wrapping of repaired tendon

Modifed kestler tendon repair wrapped by ADM ( Pelnac)

Sponsors

Aswan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* recent hand cut tendon

Exclusion criteria

1. All patients less than 16 years old. 2. Zone 1 , 3 , 4 and zone 5 flexor tendon injuries. 3. Patients with flexor pollicis longus tendon injury. 4. Severely lacerated or crushed tendons. 5. Tendon defects. 6. Multiple level tendon injuries. 7. Associated injuries to muscles. 8. Associated hand or forearm fractures. 9. Patients with poor general condition. 10. Patients with limited passive hand movements. 11. Soft tissues defects overlying the repaired tendons.

Design outcomes

Primary

MeasureTime frameDescription
Number of participant with treatment related limitation of Movement6 months postoperativeBuck-Gramcko II criteria
Number of participant who have fibrous adhesions in Ultra sonography6 months poostoperativemuscloskeletal ultrasonography

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026