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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
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 soft-tissue defects, dorsal branch of the digital artery, regional flap

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 22, 2018
    Last Updated
    October 22, 2018
    Sponsor
    The Second Hospital of Tangshan
    Collaborators
    Chinese PLA General Hospital
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    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
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    Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps

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