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| ID | Type | Description | Link |
|---|---|---|---|
| CHS1301-00146 | Other Identifier | Hebei Clinical Trail Committee |
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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical flap | Experimental | The neurocutaneous island flap is based on the dorsal branch of the digital nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the neurocutaneous island flap | Device | The neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers. |
| Measure | Description | Time Frame |
|---|---|---|
| Discriminatory Sensation of the Flap | Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up. | 18 months to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cold Intolerance | We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). | 18 months to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Tangshan | Tangshan | Hebei | 063000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20888502 | Result | Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011. | |
| 24774037 | Derived | Wang B, Zhao Y, Lu A, Chen C. Ulnar nerve deep branch compression by a ganglion: a review of nine cases. Injury. 2014 Jul;45(7):1126-30. doi: 10.1016/j.injury.2014.03.017. Epub 2014 Apr 3. |
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No wash out, run-in or transition happened in our study.
From February of 2008 to March of 2011,12 patients with soft tissue defects in the middle phalanx or the proximal interphalangeal joint were included in the study.The type of location is medical clinic. These patients were treated with the neurocutaneous island flap.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Flap | The neurocutaneous island flap is based on the dorsal branch of the digital nerve |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The participants with a follow-up period ≥18 months were included for this Baseline Measure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Flap | The neurocutaneous island flap is based on the dorsal branch of the digital nerve |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Discriminatory Sensation of the Flap | Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up. | Posted | Mean | Standard Deviation | mm | 18 months to 24 months |
|
One year
The only Adverse Event assessed for this study was Partial distal flap necrosis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Flap | The neurocutaneous island flap is based on the dorsal branch of the digital nerve |
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The samples of our study are small, and the results may change as our experience grows.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chao Chen | The Second Hospital of Tangshan | 86-13700350471 | ts_chenchao@163.com |
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|
| 23871427 | Derived | Chen C, Tang P, Zhang L. Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap. Injury. 2013 Nov;44(11):1607-14. doi: 10.1016/j.injury.2013.06.025. Epub 2013 Jul 18. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Tissue reconstruction with the neurocutaneous island flap | The patients treated with the he neurocutaneous island flap are included in the study | Number | participants |
|
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| Secondary | Cold Intolerance | We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). | Not Posted | 18 months to 24 months | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
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