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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01533337
Other study ID # Tschen3886
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2007
Est. completion date October 2011

Study information

Verified date February 2012
Source The Second Hospital of Tangshan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. The data were compared with those of the contralateral, uninjured hand.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 2011
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender All
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria: 1. soft tissue defects in the fingertip, pulp, or volar surface of the digits; 2. a defect > 2 cm in length; 3. unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and 4. the patient refuses to use tissues from the toe. Exclusion Criteria: 1. soft tissue defects in the dorsum of the digits; 2. a defect < 2 cm in length; 3. homodigital and heterodigital island flaps are available.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Free dorsal digital flap
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Second Hospital of Tangshan Chinese PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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