NCT01533337

Brief Summary

The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
Last Updated

January 22, 2024

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

February 10, 2012

Last Update Submit

January 19, 2024

Conditions

Keywords

dorsal digital free flapdorsal branch of proper digital nervedorsal branch of proper digital arteryproper digital artery

Outcome Measures

Primary Outcomes (1)

  • static 2-point discrimination (2PD) test

    The test points were at the centers of the radial and ulnar portions of the digital pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.

    25 months

Study Arms (1)

finger

OTHER

Free dorsal digital flap transferring is used for reconstruction of soft-tissue defects

Procedure: Free dorsal digital flap

Interventions

The dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint.

finger

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • soft tissue defects in the fingertip, pulp, or volar surface of the digits;
  • a defect \> 2 cm in length;
  • unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and
  • the patient refuses to use tissues from the toe.

You may not qualify if:

  • soft tissue defects in the dorsum of the digits;
  • a defect \< 2 cm in length;
  • homodigital and heterodigital island flaps are available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 15, 2012

Study Start

May 1, 2007

Primary Completion

May 1, 2009

Study Completion

October 1, 2011

Last Updated

January 22, 2024

Record last verified: 2012-02