An interventional study of innervated sensate flap in Soft Tissue Defect of Digit, sponsored by The Second Hospital of Tangshan. Completed. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-01.
Sponsored by The Second Hospital of Tangshan · Not applicable, Interventional, and Treatment
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.
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.
The Second Hospital of Tangshan is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
the donor nerve harvested with the flap
Procedure: innervated sensate flap
sensory reconstruction via digital nerve repair with the donor nerve of the flap
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.
Time frame: 18 months to 24 months after surgery
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.
Time frame: 18 months to 24 months after surgery
No study locations are listed for this record.
Plan to share: Yes
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Tangshan