Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

Sponsor

The Second Hospital of Tangshan (Other)

Overall Status

Completed

CT.gov ID

NCT01767727

Collaborator

Chinese PLA General Hospital (Other)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Finger Injuries Soft Tissue Injuries	Procedure: Soft tissue coverage	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Surgical flap Surgical flap is based on the dorsal branch of the digital artery, and is used for soft tissue coverageof multiple finger defects.	Procedure: Soft tissue coverage The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects

Arm

Intervention/Treatment

Other: Surgical flap

Surgical flap is based on the dorsal branch of the digital artery, and is used for soft tissue coverageof multiple finger defects.

Procedure: Soft tissue coverage

The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects

Outcome Measures

Primary Outcome Measures

static two-point discrimination [postoperative 18-24 months]
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 [Postoperative 18-24 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

concomitant injuries to local tissue around the defect that precluded its use as donor site;
a defect < 1.5 cm and ≥ 3.5 cm in length;
a finger degloving injury;
the defect of the thumb.