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A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01826539
Enrollment
71
Registered
2013-04-08
Start date
2011-01-31
Completion date
2012-09-30
Last updated
2013-04-08

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

Conditions

Soft Tissue Defect of the Finger

Keywords

Dorsal digital nerve, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital island flap, finger pulp defect.

Brief summary

As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.

Detailed description

The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.

Interventions

PROCEDUREflap includes a donor nerve

the donor nerve is attached with the flap for sensory reconstruction of the finger

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
The Second Hospital of Tangshan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
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

* The pulp or fingertip defect in only one finger * A defect greater than or equal to 1.5 cm in length * Necessity to preserve finger length * A patient between 18 and 60 years of age

Exclusion criteria

* Injuries to the dorsum of the middle phalanx * Injuries to the course of the vascular pedicle or donor nerve * A defect less than 1.5 cm in length * Multiple finger pulp defect * Extremely contaminated wounds

Design outcomes

Primary

MeasureTime frameDescription
static 2-point discrimination (2PD) test18 months to 26 monthsThe test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. We stop at 4mm as a limit of 2PD and consider this normal.

Secondary

MeasureTime frameDescription
Cold intolerance18 months to 26 monthsCold intolerance in the reconstructed finger is assessed using the self-administered Cold Intolerance Severity Score questionnaire \[10\]. The maximum score is 100 and was group into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.

Other

MeasureTime frameDescription
Pain18 months to 26 monthsUsing the visual analogue scale (VAS), patients are asked to report pain sensations of the reconstructed pulps and donor sites. The VAS consists of a 10 cm line that is 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