Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap
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|ClinicalTrials.gov Identifier: NCT01837407|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Complex Digital Injuries||Procedure: Composite Flap||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||March 2013|
The flap includes the nerve for repair of the soft tissue and nerve defects
Procedure: Composite Flap
nerve transfer with the dorsal branch of the digital nerve
- Static 2-point discrimination test [ Time Frame: 18 months to 24 months ]The test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. The investigators stop at 4mm as a limit of 2PD and consider this normal.
- Cold Intolerance Severity Score (CISS) questionnaire. [ Time Frame: 18 months to 24 months ]The maximum score is 100 and is grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.
- Visual analog scale [ Time Frame: 18 months to 24 months ]The VAS consists of a 10-cm line that was grouped into mild (0-3 cm), moderate (4-6 cm), and severe (7-10 cm).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837407
|The Second Hospital of Tangshan|
|Tangshan, Hebei, China, 063000|