Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
Primary Purpose
Finger Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
flap transferring
Sponsored by
About this trial
This is an interventional treatment trial for Finger Injuries focused on measuring soft-tissue defects, dorsal branch of the digital artery, regional flap
Eligibility Criteria
Inclusion Criteria:
- the separate soft tissue defects with exposed bone or tendon in different digits
- the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
- necessity to preserve digit length
- local tissue near the defect can be used as the donor
- a patient between 15 and 60 years of age
Exclusion Criteria:
- concomitant injuries to the dorsum of the injured finger
- a defect < 1.5 cm and>3.5 cm in length
- a finger degloving injury
- the defect of the thumb
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
flaps
Arm Description
flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects
Outcomes
Primary Outcome Measures
Static 2PD test
We use a Disk-Criminator to test two nearby points when touching the flap
Secondary Outcome Measures
Full Information
NCT ID
NCT03717220
First Posted
October 22, 2018
Last Updated
October 22, 2018
Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03717220
Brief Title
Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
Official Title
Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 15, 2008 (Actual)
Primary Completion Date
May 10, 2016 (Actual)
Study Completion Date
July 30, 2016 (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
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.
Detailed Description
For the recipient where sensory restoration is important, sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Injuries
Keywords
soft-tissue defects, dorsal branch of the digital artery, regional flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flaps
Arm Type
Other
Arm Description
flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects
Intervention Type
Procedure
Intervention Name(s)
flap transferring
Intervention Description
we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects
Primary Outcome Measure Information:
Title
Static 2PD test
Description
We use a Disk-Criminator to test two nearby points when touching the flap
Time Frame
18 months to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
the separate soft tissue defects with exposed bone or tendon in different digits
the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
necessity to preserve digit length
local tissue near the defect can be used as the donor
a patient between 15 and 60 years of age
Exclusion Criteria:
concomitant injuries to the dorsum of the injured finger
a defect < 1.5 cm and>3.5 cm in length
a finger degloving injury
the defect of the thumb
12. IPD Sharing Statement
Citations:
PubMed Identifier
23810451
Citation
Chen C, Tang P, Zhang L, Li X, Zheng Y. Repair of multiple finger defects using the dorsal homodigital island flaps. Injury. 2013 Nov;44(11):1582-8. doi: 10.1016/j.injury.2013.05.019. Epub 2013 Jun 28.
Results Reference
background
Learn more about this trial
Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
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