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

October 22, 2018 updated by: The Second Hospital of Tangshan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static 2PD test
Time Frame: 18 months to 24 months
We use a Disk-Criminator to test two nearby points when touching the flap
18 months to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Tangshan

Collaborators

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2008

Primary Completion (Actual)

May 10, 2016

Study Completion (Actual)

July 30, 2016

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSChen13476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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