Soft Tissue DefectNCT01871103
The Dorsal Homodigital Island Flap Based on the Dorsal Branch of the Digital Artery: A Review of 171 Cases
A study testing The dorsal homodigital island flap in people with Soft Tissue Defect and Sensory Reconstruction of Digits, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Defect, Sensory Reconstruction of Digits, Multiple Digital Defects
- What is being tested?
- The dorsal homodigital island flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteChina
- Study dates
- Jan 2006to Mar 2013
- 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 soft tissue defect in one finger or in multiple fingers
- a defect > 1.5 cm and < 3 cm in length
- necessity to preserve finger length
- a patient between 15 and 60 years of age
Who cannot join
- injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
- a defect≤1.5 cm or ≥3 cm in length
- a soft tissue defect of the thumb
Trial locations and contacts
1 site in 1 country.
About this study
Soft tissue reconstruction in the finger continues to evolve. 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 homodigital island flap can be used as a reliable alternative for reconstructing small to moderate defects of the fingers. In this retrospective study, the investigators would evaluate the efficacy of the technique for tissue reconstruction in different regions of the finger, with an emphasis on sensibility, pain and donor site morbidity.
Read the detailed description
At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination test and Semmes-Weinstein monofilament test. We evaluate pain sensations of the reconstructed fingers and donor sites with a visual analog scale. The system consist of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Active motion of the joints is measured using a goniometer. The motion arcs of the reconstructed fingers are compared with the opposite side.
- Being tested
- The dorsal homodigital island flap
- Keywords
- Soft tissue defect, dorsal branch of the digital artery, dorsal branch of the digital nerve, dorsal homodigital island flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The dorsal homodigital island flapProcedure or surgery
The dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger.
| Study group | Role | What they receive |
|---|---|---|
| Surgical flap | Other | The dorsal homodigital island flap is a perforator type flap based on the DB, which uses the dorsal skin of the injured finger to provide soft tissue coverage for a volar defect. Receives: Procedure: The dorsal homodigital island flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static 2-point discrimination test
The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stop at 4mm as a limit of 2PD and considered this normal.
Measured: 18 months to 24 months
Secondary outcomes (1)
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).
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 posted6 Jun 2013 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue DefectStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 173 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
- NCT01871103
- Sponsor's protocol ID
- HBTS1306017
- Status last verified
- Jan 2007
- First submitted
- 3 Jun 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 22777035Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016.
PubMed 24675204
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dorsal Homodigital Island Flap Based on the Dorsal Branch of the Digital Artery: A Review of 171 Cases
- ClinicalTrials.gov ID
- NCT01871103
- Acronym / sponsor ID
- HBTS1306017
- Keywords
- Soft tissue defect, dorsal branch of the digital artery, dorsal branch of the digital nerve, dorsal homodigital island flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Jun 2013 (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.
Soft tissue reconstruction in the finger continues to evolve. 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 homodigital island flap can be used as a reliable alternative for reconstructing small to moderate defects of the fingers. In this retrospective study, the investigators would evaluate the efficacy of the technique for tissue reconstruction in different regions of the finger, with an emphasis on sensibility, pain and donor site morbidity.
Detailed description
At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination test and Semmes-Weinstein monofilament test. We evaluate pain sensations of the reconstructed fingers and donor sites with a visual analog scale. The system consist of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Active motion of the joints is measured using a goniometer. The motion arcs of the reconstructed fingers are compared with the opposite side.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical flap | Other | Procedure: The dorsal homodigital island flapThe dorsal homodigital island flap is a perforator type flap based on the DB, which uses the dorsal skin of the injured finger to provide soft tissue coverage for a volar defect. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- the soft tissue defect in one finger or in multiple fingers
- a defect > 1.5 cm and < 3 cm in length
- necessity to preserve finger length
- a patient between 15 and 60 years of age
Key exclusion criteria (3 listed)
- injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
- a defect≤1.5 cm or ≥3 cm in length
- a soft tissue 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 |
|---|---|---|
| The dorsal homodigital island flapThe dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger. | Procedure or surgery | Surgical flap |
Primary outcome
Static 2-point discrimination test
Time frame: 18 months to 24 months
The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stop at 4mm as a limit of 2PD and considered this normal.
1 secondary outcome
Cold intolerance
Time frame: 18 months to 24 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 6 Jun 2013.
- Results publication: PubMed 22777035Chen 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.
- Derived from this study: PubMed 24675204Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016.
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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 dorsal homodigital island flap in people with Soft Tissue Defect and Sensory Reconstruction of Digits, 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 4 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 Jun 2013. 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 (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 NCT01871103, which also lists 2 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 Jun 2013.