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

NCT ID: NCT03717220

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-15

Study Completion Date

2016-07-30

Brief Summary

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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

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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.

Conditions

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Finger Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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flaps

flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects

Group Type OTHER

flap transferring

Intervention Type PROCEDURE

we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects

Interventions

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flap transferring

we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Tangshan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 23810451 (View on PubMed)

Other Identifiers

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TSChen13476

Identifier Type: -

Identifier Source: org_study_id

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