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CompletedNCT02167646Updated Oct 29, 2018

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

An interventional study of Flap including bilateral nerve branches in Soft Tissue Injuries, sponsored by The Second Hospital of Tangshan. Completed at 1 site in China. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-29.

Sponsored by The Second Hospital of Tangshan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Not applicable
Ages
15 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Soft Tissue Injuries

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Keywords

  • Soft tissue defect
  • dorsal branch of the digital nerve
  • dorsal branch of the digital artery
  • dorsal digital flap
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In context

Soft Tissue Injuries

61 studies on the registry are indexed under Soft Tissue Injuries; 9 are open to participants now.

This study's enrollment of 73 is above the median of 65 across 48 interventional studies indexed under Soft Tissue Injuries.

Browse Soft Tissue Injuries studies →

Lead sponsor

The Second Hospital of Tangshan is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
73 participants (actual)

Study arms

  • Other
    Bilaterally innervated flap

    Two nerve branches attached with the flap for sensory reconstruction.

    Procedure: Flap including bilateral nerve branches

Interventions

  • ProcedureFlap including bilateral nerve branches

    Two nerve branches are attached with the flap for sensory coverage

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What researchers measure

Primary outcomes

  1. Static 2PD test

    We use a Disk-Criminator to test two nearby points when touching the flap

    Time frame: 18 months to 24 months after surgery

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Study locations

1 site
  • The Second Hospital of Tangshan
    Tangshan, Hebei 063000, China
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References and documents

Publications

  • Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016. PubMed 24675204 ↗
  • Chen C, Tang P, Zhao G. Bilaterally innervated dorsal digital flap for sensory reconstruction of digits. Injury. 2014 Dec;45(12):2018-24. doi: 10.1016/j.injury.2014.09.012. Epub 2014 Sep 22. PubMed 25304161 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02167646
Lead sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital
Responsible party
Sponsor
First posted
Jun 19, 2014
Start date
Jan 2008
Primary completion
Apr 2011
Completion
Aug 2013
Last update
Oct 29, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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