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Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

Primary Purpose

Finger Injuries, Soft Tissue Injuries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Soft tissue coverage
Sponsored by
The Second Hospital of Tangshan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Finger Injuries focused on measuring surgical flap;, dorsal branch of the digital artery

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Second Hospital of Tangshan

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgical flap

Arm Description

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

Outcomes

Primary Outcome Measures

static two-point discrimination
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
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.

Full Information

First Posted
January 10, 2013
Last Updated
October 25, 2018
Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01767727
Brief Title
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
Official Title
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Injuries, Soft Tissue Injuries
Keywords
surgical flap;, dorsal branch of the digital artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical flap
Arm Type
Other
Arm Description
Surgical flap is based on the dorsal branch of the digital artery, and is used for soft tissue coverageof multiple finger defects.
Intervention Type
Procedure
Intervention Name(s)
Soft tissue coverage
Intervention Description
The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects
Primary Outcome Measure Information:
Title
static two-point discrimination
Description
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.
Time Frame
postoperative 18-24 months
Secondary Outcome Measure Information:
Title
Cold intolerance of the injured finger
Description
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.
Time Frame
Postoperative 18-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
The Second Hospital of Tangshan
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
16335381
Citation
Hu HT, Chen WH, Liu WC, Hang QW. [Fingertip reconstruction using a volar flap based on the transverse palmar branch of the digital artery]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2005 Sep;21(5):353-5. Chinese.
Results Reference
background
PubMed Identifier
14745267
Citation
Al-Qattan MM. Technical modifications and extended applications of the distally based adipofascial flap for dorsal digital defects. Ann Plast Surg. 2004 Feb;52(2):168-73. doi: 10.1097/01.sap.0000101954.16674.99.
Results Reference
result

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Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

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