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Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap

Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01778296
Enrollment
12
Registered
2013-01-29
Start date
2008-01-31
Completion date
2012-10-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory Reconstruction of the Volar Aspect of the Finger, The Heterodigital Neurocutaneous Island Flap

Keywords

Dorsal branch of the digital nerve;, dorsal digital artery;, dorsal digital island flap;, neurocutaneous island flap.

Brief summary

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.

Detailed description

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.

Interventions

DEVICEthe neurocutaneous island flap

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.

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
The Second Hospital of Tangshan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Discriminatory Sensation of the Flap18 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.

Secondary

MeasureTime frameDescription
Cold Intolerance18 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).

Countries

China

Participant flow

Recruitment details

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.

Pre-assignment details

No wash out, run-in or transition happened in our study.

Participants by arm

ArmCount
Surgical Flap
The neurocutaneous island flap is based on the dorsal branch of the digital nerve
12
Total12

Baseline characteristics

CharacteristicSurgical Flap
Age, Categorical
<=18 years
1 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
Age, Continuous34.5 years
STANDARD_DEVIATION 9.4
Region of Enrollment
China
12 participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
9 Participants
Tissue reconstruction with the neurocutaneous island flap12 participants
1.2

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

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.

Time frame: 18 months to 24 months

ArmMeasureValue (MEAN)Dispersion
Surgical FlapDiscriminatory Sensation of the Flap8.3 mmStandard Deviation 1.6
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).

Time frame: 18 months to 24 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026