Trial Outcomes & Findings for Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap (NCT NCT01778296)
NCT ID: NCT01778296
Last Updated: 2024-02-14
Results Overview
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.
COMPLETED
NA
12 participants
18 months to 24 months
2024-02-14
Participant Flow
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.
No wash out, run-in or transition happened in our study.
Participant milestones
| Measure |
Surgical Flap
The neurocutaneous island flap is based on the dorsal branch of the digital nerve
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap
Baseline characteristics by cohort
| Measure |
Surgical Flap
n=12 Participants
The neurocutaneous island flap is based on the dorsal branch of the digital nerve
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
12 participants
n=5 Participants
|
|
Tissue reconstruction with the neurocutaneous island flap
|
12 participants
1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 18 months to 24 monthsDiscriminatory 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.
Outcome measures
| Measure |
Surgical Flap
n=12 Participants
The neurocutaneous island flap is based on the dorsal branch of the digital nerve
|
|---|---|
|
Discriminatory Sensation of the Flap
|
8.3 mm
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 18 months to 24 monthsWe 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).
Outcome measures
Outcome data not reported
Adverse Events
Surgical Flap
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place