TransplantationISCFNCT01019811
Innervated Sensory Cross-Finger Flap
A study testing The innervated sensory cross-finger flap in people with Transplantation, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
The purpose of this study is to introduce a new operative technique for reconstruction of fingertip degloving injury. Read more about this study
- Who is it for?
- Ages 12 to 59 years
- Conditions the study is for
- Transplantation
- What is being tested?
- The innervated sensory cross-finger flap
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- May 2001to May 2008
- 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 12 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- the fingertip degloving injury including the thumb;
- age between 12 and 59 years;
- no life-threatening associated injuries.
Who cannot join
- age greater than 60 years;
- smoking;
- Dupuytren's contracture;
- peripheral arterial disease and other vascular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Innervated Sensory Cross-finger Flap Based on the Dorsal Branch Artery for Reconstruction of Fingertip Degloving Injury
The purpose of this study is to introduce a new operative technique for reconstruction of fingertip degloving injury.
Read the detailed description
Incidence of fingertip degloving injury is common and can result in functional morbidity. A cross-finger flap based on the dorsal branch artery (DBA) including sensory nerve is a useful reconstructive technique.In our modification, the innervated sensory flap is vascularized by the DBA, both its pedicle is narrow and its coverage is extended, the projecting tip of exposed distal phalanx of adjacent digits therefore can be wrapped.
- Conditions
- Transplantation
- Being tested
- The innervated sensory cross-finger flap
- Keywords
- Cross-finger flap, finger injuries, fingertip reconstruction, proper digital artery, proper digital nerve.
- Medical subject headings
- Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The innervated sensory cross-finger flapProcedure or surgery
The innervated sensory cross-finger flap is a modified method for repair fingertip degloving injury
What is being measured
The primary outcome is the main question the study is designed to answer.
static 2-point discrimination test and the range of motion are used for evaluation of outcomes
Measured: at least 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMay 2001
- Primary completionMay 2006
- Study completionMay 2008
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 TransplantationStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019811
- Sponsor's protocol ID
- STS-5xb-86
- Acronym
- ISCF
- Status last verified
- Nov 2009
- First submitted
- 20 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang W, Zhang X, Liu Y, Xu T, Zhuang Y, Chen C. Repair of Fingertip Degloving Injuries Using the Extended Reverse Second Dorsal Metacarpal Artery Flap. Plast Reconstr Surg. 2024 Jul 1;154(1):133-141. doi: 10.1097/PRS.0000000000010939. Epub 2023 Jul 25.
PubMed 37498313
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Innervated Sensory Cross-finger Flap Based on the Dorsal Branch Artery for Reconstruction of Fingertip Degloving Injury
- ClinicalTrials.gov ID
- NCT01019811
- Acronym / sponsor ID
- ISCF / STS-5xb-86
- Conditions
- Transplantation
- Keywords
- Cross-finger flap, finger injuries, fingertip reconstruction, proper digital artery, proper digital nerve.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Study start
- May 2001
- Primary completion
- May 2006 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Nov 2009 (estimated)
- 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.
The purpose of this study is to introduce a new operative technique for reconstruction of fingertip degloving injury.
Detailed description
Incidence of fingertip degloving injury is common and can result in functional morbidity. A cross-finger flap based on the dorsal branch artery (DBA) including sensory nerve is a useful reconstructive technique.In our modification, the innervated sensory flap is vascularized by the DBA, both its pedicle is narrow and its coverage is extended, the projecting tip of exposed distal phalanx of adjacent digits therefore can be wrapped.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- the fingertip degloving injury including the thumb;
- age between 12 and 59 years;
- no life-threatening associated injuries.
Key exclusion criteria (4 listed)
- age greater than 60 years;
- smoking;
- Dupuytren's contracture;
- peripheral arterial disease and other vascular disorders.
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 |
|---|---|---|
| The innervated sensory cross-finger flapThe innervated sensory cross-finger flap is a modified method for repair fingertip degloving injury | Procedure or surgery | – |
Primary outcome
static 2-point discrimination test and the range of motion are used for evaluation of outcomes
Time frame: at least 4 months
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 25 Nov 2009.
- Derived from this study: PubMed 37498313Zhang W, Zhang X, Liu Y, Xu T, Zhuang Y, Chen C. Repair of Fingertip Degloving Injuries Using the Extended Reverse Second Dorsal Metacarpal Artery Flap. Plast Reconstr Surg. 2024 Jul 1;154(1):133-141. doi: 10.1097/PRS.0000000000010939. Epub 2023 Jul 25.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The innervated sensory cross-finger flap in people with Transplantation, run by The Second Hospital of Tangshan at 1 site in China.
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 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 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 and the range of motion are used for evaluation of outcomes (time frame: at least 4 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 NCT01019811, 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 25 Nov 2009.