Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02167646

Enrollment

Registered

2014-06-19

Start date

2008-01-31

Completion date

2013-08-31

Last updated

2018-10-29

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

Conditions

Soft Tissue Injuries

Keywords

Soft tissue defect, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital flap

Brief summary

Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

Detailed description

Pain was given subjectively by the patient using the visual analogue scale (VAS). 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). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

Interventions

PROCEDUREFlap including bilateral nerve branches

Two nerve branches are attached with the flap for sensory coverage

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger * the defect associated with the transected digital nerves in both sides * a defect greater than 1.5 cm * a patient aged 15 to 60 years

Exclusion criteria

* injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor * injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap * a defect less than or equal to 1.5 cm * patient age \< 15 years or \> 60 years

Design outcomes

Primary

Measure	Time frame	Description
Static 2PD test	18 months to 24 months after surgery	We use a Disk-Criminator to test two nearby points when touching the flap

Countries

China

Outcome results

None listed

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