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TraumaNCT01486719

Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap

A study testing Sensate Dorsal Digital Island Flap in people with Trauma, run by The Second Hospital of Tangshan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sensory reconstruction of the finger pulp is a challenging problem. This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration. Read more about this study

Who is it for?
Ages 15 to 60 years
Conditions the study is for
Trauma
What is being tested?
Sensate Dorsal Digital Island Flap
Type of treatment
Surgery or procedure
How many people
12 participants
Where
No sites listed yet
Study dates
Feb 2008to Mar 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • a finger pulp defect > 1.5 cm in length
  • necessity to preserve finger length
  • patients younger than 60 years .

Who cannot join

  • injury to the dorsum of the middle phalanx of the reconstructed finger that precluded its use as donor site
  • injury to the course of the vascular pedicle or opposite PDA
  • defects < 1.5 cm in length.

About this study

Sensory reconstruction of the finger pulp is a challenging problem. This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.

Read the detailed description

From February 2008 to May 2009, the flap harvested from the dorsum of the middle phalanx of the same finger was used in 12 fingers in 12 patients. The flaps ranged in size from 2.0 × 2.0 cm to 2.8 × 2.2 cm. The mean pedicle length was 1.2 cm. Neurorrhaphy between the dorsal branches of the PDN and PDN was performed in both sides in all cases. Sensibility of the reconstructed finger pulp was evaluated by static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test. The range of motion of the donor fingers was measured. The data were compared to those of the opposite sides.

Conditions
Trauma
Being tested
Sensate Dorsal Digital Island Flap
Keywords
Finger pulp reconstruction, dorsal branch, proper digital nerve, palmar arterial arch, dorsal digital island flap
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensate Dorsal Digital Island FlapProcedure or surgery

    Also called Surgical Flap, Island Flap

    This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. static 2-point discrimination test

    The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments. Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps. These measurements were compared with those on the contralateral site. According to the Michigan Hand Outcomes Questionnaire (MHQ), patients reported their satisfaction with the appearance of the injured hand. The questions based on a 5-point response scale.

    Measured: Patients were followed for 16-23 months (mean, 19 months)

Secondary outcomes (1)

  1. Semmes-Weinstein monofilament test

    The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments. Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps. These measurements were compared with those on the contralateral site.

    Measured: Patients were followed for 16-23 months (mean, 19 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2011 (estimated)
  2. Study startFeb 2008
  3. Primary completionMay 2009
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01486719
Sponsor's protocol ID
CHEN-19750306
Status last verified
Dec 2011
First submitted
4 Dec 2011
Last updated
6 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Bene MD, Petrolati M, Raimondi P, Tremolada C, Muset A. Reverse dorsal digital island flap. Plast Reconstr Surg. 1994 Mar;93(3):552-7.

    PubMed 8115510

  • Pelissier P, Casoli V, Bakhach J, Martin D, Baudet J. Reverse dorsal digital and metacarpal flaps: a review of 27 cases. Plast Reconstr Surg. 1999 Jan;103(1):159-65. doi: 10.1097/00006534-199901000-00025.

    PubMed 9915177

  • Chen C, Tang P, Zhang X. Sensory reconstruction of a finger pulp defect using a dorsal homodigital island flap. Plast Reconstr Surg. 2012 Nov;130(5):1077-1086. doi: 10.1097/PRS.0b013e318267ef99.

    PubMed 22777035

Questions about this trial

What is this clinical trial studying?

A study testing Sensate Dorsal Digital Island Flap in people with Trauma, run by The Second Hospital of Tangshan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

static 2-point discrimination test (time frame: Patients were followed for 16-23 months (mean, 19 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01486719, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.

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