Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
1 other identifier
interventional
12
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2007
Longer than P75 for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedJanuary 22, 2024
February 1, 2012
2 years
February 10, 2012
January 19, 2024
Conditions
Keywords
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
OTHERFree dorsal digital flap transferring is used for reconstruction of soft-tissue defects
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.
Eligibility Criteria
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
- The Second Hospital of Tangshanlead
- Chinese PLA General Hospitalcollaborator
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