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

A

Aswan University

Status

Completed

Conditions

Tendon Injury - Hand

Treatments

Procedure: ADM (Pelnac) wrapping of repaired tendon
Procedure: Fascial wrapping the site of tendon repair
Procedure: Modified Kestler tendon repair

Study type

Interventional

Funder types

Other

Identifiers

NCT07074223
Tendon fascial graft

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups, including a placebo group

Control Group
Placebo Comparator group
Description:
Modefied kestler tendon repair
Treatment:
Procedure: Modified Kestler tendon repair
Pelnac Group
Experimental group
Description:
Modified kestler tendon repair wrapped by Pelnac
Treatment:
Procedure: ADM (Pelnac) wrapping of repaired tendon
Fascia Group
Experimental group
Description:
modefied kestler tendon repair wrapped by fascial graft
Treatment:
Procedure: Fascial wrapping the site of tendon repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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