Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

This study has been completed.
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01767727
First received: January 10, 2013
Last updated: January 11, 2013
Last verified: October 2012
  Purpose

Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. At the final follow-up, we would evaluate the efficacy of this technique.


Condition Intervention
Multiple Finger Defects;
Dorsal Homodigital Island Flap;
Procedure: Soft tissue coverage

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Second Hospital of Tangshan:

Primary Outcome Measures:
  • static two-point discrimination [ Time Frame: postoperative 18-24 months ] [ Designated as safety issue: No ]
    The test points are at the center of the flap.Each area is tested 3 times with a Discriminator. We stopp at 4 mm as a limit of two-point discrimination and consider this normal.


Secondary Outcome Measures:
  • Cold intolerance of the injured finger [ Time Frame: Postoperative 18-24 months ] [ Designated as safety issue: No ]
    The cold intolerance of the injured finger was measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme.


Enrollment: 12
Study Start Date: March 2008
Study Completion Date: October 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgical flap
The dorsal homodigital island flaps is based on the dorsal branch of the digital artery, and is used for reconstruction of multiple finger defects.
Procedure: Soft tissue coverage
The dorsal homodigital island flaps are used for reconstruction of multiple finger defects

Detailed Description:

At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme. The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. a patient who had separate soft tissue defects in different fingers in same hand;
  2. the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
  3. local tissue near the defect is uninjured; and
  4. a patient between 15 and 60 years of age.

Exclusion Criteria:

  1. concomitant injuries to local tissue around the defect that precluded its use as donor site;
  2. a defect < 1.5 cm and ≥ 3.5 cm in length;
  3. a finger degloving injury;
  4. the defect of the thumb.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01767727

Locations
China, Hebei
The Second Hospital of Tangshan
Tangshan, Hebei, China, 063000
Sponsors and Collaborators
The Second Hospital of Tangshan
Chinese PLA General Hospital
  More Information

Publications:
Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01767727     History of Changes
Other Study ID Numbers: HB-TS-0130067
Study First Received: January 10, 2013
Last Updated: January 11, 2013
Health Authority: China: Ethics Committee

Keywords provided by The Second Hospital of Tangshan:
surgical flap;
dorsal branch of the digital artery

ClinicalTrials.gov processed this record on July 20, 2014