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Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps

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ClinicalTrials.gov Identifier: NCT03717220
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Finger Injuries Procedure: flap transferring Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
Actual Study Start Date : July 15, 2008
Actual Primary Completion Date : May 10, 2016
Actual Study Completion Date : July 30, 2016

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Arms and Interventions
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Arm Intervention/treatment
flaps
flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects
 Procedure: flap transferring
we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects


Outcome Measures
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Primary Outcome Measures :
  1. Static 2PD test [ Time Frame: 18 months to 24 months ]
    We use a Disk-Criminator to test two nearby points when touching the flap


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications:

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Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT03717220    
Other Study ID Numbers: TSChen13476
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Hospital of Tangshan:
soft-tissue defects
dorsal branch of the digital artery
regional flap
Additional relevant MeSH terms:
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Finger Injuries
Hand Injuries
Wounds and Injuries