NCT07074223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 28, 2025

Last Update Submit

July 10, 2025

Conditions

Tendon Injury - Hand

Outcome Measures

Primary Outcomes (2)

  • Number of participant with treatment related limitation of Movement

    Buck-Gramcko II criteria

    6 months postoperative

  • Number of participant who have fibrous adhesions in Ultra sonography

    muscloskeletal ultrasonography

    6 months poostoperative

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Modefied kestler tendon repair

Procedure: Modified Kestler tendon repair

Pelnac Group

EXPERIMENTAL

Modified kestler tendon repair wrapped by Pelnac

Procedure: ADM (Pelnac) wrapping of repaired tendon

Fascia Group

EXPERIMENTAL

modefied kestler tendon repair wrapped by fascial graft

Procedure: Fascial wrapping the site of tendon repair

Interventions

Fascial wrapping the site of tendon repairPROCEDURE

wrapping the tendon repair site by Pelnac or Fascial graft

Fascia Group
Modified Kestler tendon repairPROCEDURE

Modified Kestler tendon repair

Control Group
ADM (Pelnac) wrapping of repaired tendonPROCEDURE

Modifed kestler tendon repair wrapped by ADM ( Pelnac)

Pelnac Group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • recent hand cut tendon

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospitals

Aswān, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of plastic surgery

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 20, 2025

Study Start

May 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 20, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)