NCT01871103

Brief Summary

Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal homodigital island flap can be used as a reliable alternative for reconstructing small to moderate defects of the fingers. In this retrospective study, the investigators would evaluate the efficacy of the technique for tissue reconstruction in different regions of the finger, with an emphasis on sensibility, pain and donor site morbidity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
Last Updated

June 6, 2013

Status Verified

January 1, 2007

Enrollment Period

3 years

First QC Date

June 3, 2013

Last Update Submit

June 5, 2013

Conditions

Keywords

Soft tissue defectdorsal branch of the digital arterydorsal branch of the digital nervedorsal homodigital island flap

Outcome Measures

Primary Outcomes (1)

  • Static 2-point discrimination test

    The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stop at 4mm as a limit of 2PD and considered this normal.

    18 months to 24 months

Secondary Outcomes (1)

  • Cold intolerance

    18 months to 24 months

Study Arms (1)

Surgical flap

OTHER

The dorsal homodigital island flap is a perforator type flap based on the DB, which uses the dorsal skin of the injured finger to provide soft tissue coverage for a volar defect.

Procedure: The dorsal homodigital island flap

Interventions

The dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger.

Surgical flap

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the soft tissue defect in one finger or in multiple fingers
  • a defect \> 1.5 cm and \< 3 cm in length
  • necessity to preserve finger length
  • a patient between 15 and 60 years of age

You may not qualify if:

  • injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
  • a defect≤1.5 cm or ≥3 cm in length
  • a soft tissue defect of the thumb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related Publications (2)

  • Chen C, Tang P, Zhang X. Sensory reconstruction of a finger pulp defect using a dorsal homodigital island flap. Plast Reconstr Surg. 2012 Nov;130(5):1077-1086. doi: 10.1097/PRS.0b013e318267ef99.

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2013

Last Updated

June 6, 2013

Record last verified: 2007-01

Locations