| Registry | NCT01778296 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 12 (Actual) |
| Sponsor | The Second Hospital of Tangshan (Other); collaborators: Chinese PLA General Hospital |
| Conditions | Sensory Reconstruction of the Volar Aspect of the Finger, The Heterodigital Neurocutaneous Island Flap |
| Interventions | the neurocutaneous island flap (Device) |
| Dates | start 2008-01-01, primary completion 2012-03-01, completion 2012-10-01, first posted 2013-01-29, last updated 2024-02-14 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Sensory Reconstruction of the Volar Aspect of the Finger All trials for The Heterodigital Neurocutaneous Island Flap All trials of the neurocutaneous island flap
The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal digital island flap can be used for repairing the defect of adjacent finger, but the limited length of the pedicle precludes its use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal branch of the digital nerve can be used as an alternative to resolve this problem.
At final follow-up, we measured the sensibility of the flaps using the Semmes-Weinstein monofilament test and the static 2-point discrimination test. The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stopped at 4mm as a limit of 2PD and considered this normal.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Surgical flap | Experimental | Device: the neurocutaneous island flap | The neurocutaneous island flap is based on the dorsal branch of the digital nerve |
Sex: All, ages: 15 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria: * the soft tissue defects involving the middle phalanx, the proximal interphalangeal joint, or both; * a defect greater than or equal to 2 cm in length; * a patient between 15 and 60 years of age. Exclusion Criteria: * concomitant injuries to the dorsal skin of the middle phalanx of adjacent finger that precluded its use as donor site; * injuries to the course of donor nerve branch; * a defect less than 1.5 cm in length; * a fingertip or pulp defect; * a soft tissue defect of the thumb.
| Milestone | Surgical Flap |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
Time frame: One year
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Surgical Flap | 0 | 0/12 (0.0%) | 0/12 (0.0%) |
Limitations and caveats: The samples of our study are small, and the results may change as our experience grows.
| Facility | City | Country | Status |
|---|---|---|---|
| The Second Hospital of Tangshan | Tangshan, Hebei | China |