Sensory Reconstruction of the Digits

Soft Tissue Defect of Digit Clinical Trial

Official title:

Sensory Reconstruction in Different Region of the Digits: A Review of 151 Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695485
• Other study ID #: TSZhao9012
• Status: Completed
• Phase: N/A
• First received: February 19, 2016
• Last updated: February 29, 2016
• Start date: February 2006
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A retrospective study is conducted with 151 patients who has a soft tissue defect of digit treated with the sensate flaps from February 2005 to March 2014. Based on the different regions of soft tissue defects, the patients in the study are divided into four groups: (1) thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region group treated with Litter flap. The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.

Description:

At final follow-up, sensory restoration of the flap is measured using the static 2PD test and Semmes-Weinstein monofilament test. Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site. Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• thumbtip degloving injury with a projecting tip of exposed bone or/and pulp defect; the defect =2 cm in length associated with the transected digital nerves in both sides; necessity to preserve thumb length; patient at or younger than 55 years of age

Exclusion Criteria:

• injury to the dorsum of the proximal or/and middle phalanx of the index finger; injury to the course of the FDMA; thumb nail bed defect; radial or ulnar portion of thumbtip or pulp defect

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Soft Tissue Defect of Digit

Intervention

Procedure:
• innervated sensate flap
sensory reconstruction via digital nerve repair with the donor nerve of the flap

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 X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-29e. doi: 10.1097/PRS.0000000000000016. — 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. It is often tested with two sharp points during a neurological examination and is assumed to reflect how finely innervated an area of flap is.	18 months to 24 months after surgery	Yes
Primary	Pain sensation using the visual analogue scale	Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site.	18 months to 24 months after surgery	Yes