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

Not Applicable

Completed

• Conditions: Finger Injuries
• Interventions: Procedure: flap transferring

• Registration Number: NCT03717220
• Lead Sponsor: The Second Hospital of Tangshan

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.

Study Timeline

• Study Start: 2008-07-15
• Primary Completion: 2016-05-10
• Study Completion: 2016-07-30
• Status Verified: 2018-06
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Study First Posted: 2018-10-24
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
flaps	flap transferring	flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects

Primary Outcome Measures

Name	Time	Method
Static 2PD test	18 months to 24 months	We use a Disk-Criminator to test two nearby points when touching the flap