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Clinical Trials/NCT07074223
NCT07074223CompletedNot Applicable

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

Aswan University1 site in 1 country30 target enrollmentStarted: May 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Number of participant with treatment related limitation of Movement

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •recent hand cut tendon

Exclusion Criteria

  • •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.
  • •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.

Arms & Interventions

Control Group

Placebo Comparator

Modefied kestler tendon repair

Intervention: Modified Kestler tendon repair (Procedure)

Pelnac Group

Experimental

Modified kestler tendon repair wrapped by Pelnac

Intervention: ADM (Pelnac) wrapping of repaired tendon (Procedure)

Fascia Group

Experimental

modefied kestler tendon repair wrapped by fascial graft

Intervention: Fascial wrapping the site of tendon repair (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Osama Hassan Elbanna

lecturer of plastic surgery

Aswan University

Study Sites (1)

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