Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837407

Enrollment

Registered

2013-04-23

Start date

2008-03-31

Completion date

2013-03-31

Last updated

2013-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Digital Injuries

Keywords

Soft tissue loss, nerve defect, dorsal branch of the proper digital nerve, heterodigital arterialized nerve pedicle flap, Composite Flap, nerve flap, nerve transfer

Brief summary

Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.

Interventions

PROCEDUREComposite Flap

nerve transfer with the dorsal branch of the digital nerve

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

15 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* a neurocutaneous defect at the proximal phalanx * a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect.

Exclusion criteria

* an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve * a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers * a nerve injury that is able to be repaired by primary neurorrhaphy

Design outcomes

Primary

Measure	Time frame	Description
Static 2-point discrimination test	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.

Secondary

Measure	Time frame	Description
Cold Intolerance Severity Score (CISS) questionnaire.	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.

Other

Measure	Time frame	Description
Visual analog scale	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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026