Finger InjuriesNCT03717220
Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
A study testing flap transferring in people with Finger Injuries, run by The Second Hospital of Tangshan.
Trial summary
Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Finger Injuries
- What is being tested?
- flap transferring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2008to 30 Jul 2016
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- the separate soft tissue defects with exposed bone or tendon in different digits
- the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
- necessity to preserve digit length
- local tissue near the defect can be used as the donor
- a patient between 15 and 60 years of age
Who cannot join
- concomitant injuries to the dorsum of the injured finger
- a defect < 1.5 cm and>3.5 cm in length
- a finger degloving injury
- the defect of the thumb
About this study
Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.
Read the detailed description
For the recipient where sensory restoration is important, 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). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, 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.
- Conditions
- Finger Injuries
- Being tested
- flap transferring
- Keywords
- soft-tissue defects, dorsal branch of the digital artery, regional flap
- Medical subject headings
- Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flap transferringProcedure or surgery
we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects
| Study group | Role | What they receive |
|---|---|---|
| flaps | Other | flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects Receives: Procedure: flap transferring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static 2PD test
We use a Disk-Criminator to test two nearby points when touching the flap
Measured: 18 months to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start15 Jul 2008
- Primary completion10 May 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Finger InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717220
- Sponsor's protocol ID
- TSChen13476
- Status last verified
- Jun 2018
- First submitted
- 22 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen C, Tang P, Zhang L, Li X, Zheng Y. Repair of multiple finger defects using the dorsal homodigital island flaps. Injury. 2013 Nov;44(11):1582-8. doi: 10.1016/j.injury.2013.05.019. Epub 2013 Jun 28.
PubMed 23810451
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps
- ClinicalTrials.gov ID
- NCT03717220
- Acronym / sponsor ID
- TSChen13476
- Conditions
- Finger Injuries
- Keywords
- soft-tissue defects, dorsal branch of the digital artery, regional flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 15 Jul 2008 (actual)
- Primary completion
- 10 May 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.
Detailed description
For the recipient where sensory restoration is important, 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). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flaps | Other | Procedure: flap transferringflap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- the separate soft tissue defects with exposed bone or tendon in different digits
- the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
- necessity to preserve digit length
- local tissue near the defect can be used as the donor
- a patient between 15 and 60 years of age
Key exclusion criteria (4 listed)
- concomitant injuries to the dorsum of the injured finger
- a defect < 1.5 cm and>3.5 cm in length
- a finger degloving injury
- the defect of the thumb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flap transferringwe use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects | Procedure or surgery | flaps |
Primary outcome
Static 2PD test
Time frame: 18 months to 24 months
We use a Disk-Criminator to test two nearby points when touching the flap
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Background: PubMed 23810451Chen C, Tang P, Zhang L, Li X, Zheng Y. Repair of multiple finger defects using the dorsal homodigital island flaps. Injury. 2013 Nov;44(11):1582-8. doi: 10.1016/j.injury.2013.05.019. Epub 2013 Jun 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing flap transferring in people with Finger Injuries, 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 5 inclusion and 4 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 24 Oct 2018. 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 2PD test (time frame: 18 months to 24 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 NCT03717220, which also lists 1 linked publication.
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 24 Oct 2018.