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Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap

Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01707654
Enrollment
9
Registered
2012-10-16
Start date
2008-07-31
Completion date
2012-02-29
Last updated
2018-11-21

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

Conditions

Disruption of Nerve Repair, Infection Wound

Keywords

defect;, dorsal branch of the proper digital nerve;, proper digital nerve;, finger sensory reconstruction.

Brief summary

A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. From July 2008 to May 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. The purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.

Detailed description

sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

Interventions

Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.

Sponsors

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
16 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* an infective wound with exposed bone or tendon in the finger; * soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both; * associated digital nerve defect 1 to 4 cm in length; * single or double nerve defects; and * simultaneous repair of nerve and soft tissue defects.

Exclusion criteria

* injury to the course of the pedicle or the donor site; * nerve defect less than 1 cm or larger than 4 cm in length; * occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb; * no involvement of the digital nerve.

Design outcomes

Primary

MeasureTime frameDescription
2-point Discrimination Test17-25 monthsThe 2-point Discrimination 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 points were at the center of the radial or ulnar portion of the pulp. 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 stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.

Secondary

MeasureTime frameDescription
Semmes-Weinstein (SW) Monofilament Test17-25 monthsThe 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.

Other

MeasureTime frameDescription
Pain17-25 monthsPain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Countries

China

Participant flow

Recruitment details

From July 2008 to May 2010, 9 patients who had a combination of soft tissue and digital nerve defects were included in the study. The type of location was medical clinic.

Pre-assignment details

No patient was lost to follow-up

Participants by arm

ArmCount
Nerve Graft
Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
9
Total9

Baseline characteristics

CharacteristicNerve Graft
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
Age, Continuous32.6 years
STANDARD_DEVIATION 6.6
Region of Enrollment
China
9 participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

2-point Discrimination Test

The 2-point Discrimination 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 points were at the center of the radial or ulnar portion of the pulp. 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 stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.

Time frame: 17-25 months

ArmMeasureValue (MEAN)Dispersion
Nerve Graft2-point Discrimination Test7.5 mmStandard Deviation 1.6
Secondary

Semmes-Weinstein (SW) Monofilament 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.

Time frame: 17-25 months

Other Pre-specified

Pain

Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Time frame: 17-25 months

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026