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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

January 10, 2013
January 11, 2013
March 2008
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01767727 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
Not Provided

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.

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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Multiple Finger Defects;
  • Dorsal Homodigital Island Flap;
Procedure: Soft tissue coverage
The dorsal homodigital island flaps are used for reconstruction of multiple finger defects
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.
Intervention: Procedure: Soft tissue coverage

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2012
August 2011   (final data collection date for primary outcome measure)

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.
Both
15 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01767727
HB-TS-0130067
Yes
The Second Hospital of Tangshan
The Second Hospital of Tangshan
Chinese PLA General Hospital
Not Provided
The Second Hospital of Tangshan
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP