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

Finger Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717220
• Other study ID #: TSChen13476
• Status: Completed
• Phase: N/A
• Start date: July 15, 2008
• Est. completion date: July 30, 2016

Study information

• Verified date: June 2018
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 30, 2016
• Est. primary completion date: May 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Finger Injuries
• Polydactyly

Intervention

Procedure:
• flap transferring
we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Tangshan	Chinese PLA General Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static 2PD test	We use a Disk-Criminator to test two nearby points when touching the flap	18 months to 24 months