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

NCT ID: NCT07074223

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tendon Injury - Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

Modefied kestler tendon repair

Group Type PLACEBO_COMPARATOR

Modified Kestler tendon repair

Intervention Type PROCEDURE

Modified Kestler tendon repair

Pelnac Group

Modified kestler tendon repair wrapped by Pelnac

Group Type EXPERIMENTAL

ADM (Pelnac) wrapping of repaired tendon

Intervention Type PROCEDURE

Modifed kestler tendon repair wrapped by ADM ( Pelnac)

Fascia Group

modefied kestler tendon repair wrapped by fascial graft

Group Type EXPERIMENTAL

Fascial wrapping the site of tendon repair

Intervention Type PROCEDURE

wrapping the tendon repair site by Pelnac or Fascial graft

Interventions

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Fascial wrapping the site of tendon repair

wrapping the tendon repair site by Pelnac or Fascial graft

Intervention Type PROCEDURE

Modified Kestler tendon repair

Modified Kestler tendon repair

Intervention Type PROCEDURE

ADM (Pelnac) wrapping of repaired tendon

Modifed kestler tendon repair wrapped by ADM ( Pelnac)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aswan University

OTHER

Sponsor Role lead

Responsible Party

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Osama Hassan Elbanna

lecturer of plastic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aswan University Hospitals

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Tendon fascial graft

Identifier Type: -

Identifier Source: org_study_id

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