Finger InjuriesNCT01767727
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
A study testing Soft tissue coverage in people with Finger Injuries and Soft Tissue Injuries, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Finger Injuries, Soft Tissue Injuries
- What is being tested?
- Soft tissue coverage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Oct 2012
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a patient who had separate soft tissue defects in different fingers in same hand;
- the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
- local tissue near the defect is uninjured; and
- a patient between 15 and 60 years of age.
Who cannot join
- concomitant injuries to local tissue around the defect that precluded its use as donor site;
- a defect < 1.5 cm and ≥ 3.5 cm in length;
- a finger degloving injury;
- the defect of the thumb.
Trial locations and contacts
1 site in 1 country.
About this study
Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. At the final follow-up, we would evaluate the efficacy of this technique.
Read the detailed description
At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme. The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).
- Conditions
- Finger Injuries, Soft Tissue Injuries
- Being tested
- Soft tissue coverage
- Keywords
- surgical flap;, dorsal branch of the digital artery
- Medical subject headings
- Finger Injuries, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue coverageProcedure or surgery
The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects
| Study group | Role | What they receive |
|---|---|---|
| Surgical flap | Other | Surgical flap is based on the dorsal branch of the digital artery, and is used for soft tissue coverageof multiple finger defects. Receives: Procedure: Soft tissue coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
static two-point discrimination
The test points are at the center of the flap.Each area is tested 3 times with a Discriminator. We stopp at 4 mm as a limit of two-point discrimination and consider this normal.
Measured: postoperative 18-24 months
Secondary outcomes (1)
Cold intolerance of the injured finger
The cold intolerance of the injured finger was measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme.
Measured: Postoperative 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startMar 2008
- Primary completionAug 2011
- Study completionOct 2012
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 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
- 12 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
- NCT01767727
- Sponsor's protocol ID
- HB-TS-0130067
- Status last verified
- Oct 2012
- First submitted
- 10 Jan 2013
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu HT, Chen WH, Liu WC, Hang QW. [Fingertip reconstruction using a volar flap based on the transverse palmar branch of the digital artery]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2005 Sep;21(5):353-5. Chinese.
PubMed 16335381Al-Qattan MM. Technical modifications and extended applications of the distally based adipofascial flap for dorsal digital defects. Ann Plast Surg. 2004 Feb;52(2):168-73. doi: 10.1097/01.sap.0000101954.16674.99.
PubMed 14745267
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
- ClinicalTrials.gov ID
- NCT01767727
- Acronym / sponsor ID
- HB-TS-0130067
- Conditions
- Finger Injuries, Soft Tissue Injuries
- Keywords
- surgical flap;, dorsal branch of the digital artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Mar 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Jan 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.
Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. At the final follow-up, we would evaluate the efficacy of this technique.
Detailed description
At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme. The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical flap | Other | Procedure: Soft tissue coverageSurgical flap is based on the dorsal branch of the digital artery, and is used for soft tissue coverageof multiple finger defects. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- a patient who had separate soft tissue defects in different fingers in same hand;
- the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
- local tissue near the defect is uninjured; and
- a patient between 15 and 60 years of age.
Key exclusion criteria (4 listed)
- concomitant injuries to local tissue around the defect that precluded its use as donor site;
- 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 |
|---|---|---|
| Soft tissue coverageThe dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects | Procedure or surgery | Surgical flap |
Primary outcome
static two-point discrimination
Time frame: postoperative 18-24 months
The test points are at the center of the flap.Each area is tested 3 times with a Discriminator. We stopp at 4 mm as a limit of two-point discrimination and consider this normal.
1 secondary outcome
Cold intolerance of the injured finger
Time frame: Postoperative 18-24 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 29 Oct 2018.
- Background: PubMed 16335381Hu HT, Chen WH, Liu WC, Hang QW. [Fingertip reconstruction using a volar flap based on the transverse palmar branch of the digital artery]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2005 Sep;21(5):353-5. Chinese.
- Results publication: PubMed 14745267Al-Qattan MM. Technical modifications and extended applications of the distally based adipofascial flap for dorsal digital defects. Ann Plast Surg. 2004 Feb;52(2):168-73. doi: 10.1097/01.sap.0000101954.16674.99.
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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 Soft tissue coverage in people with Finger Injuries and Soft Tissue Injuries, 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 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 29 Oct 2018. 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 two-point discrimination (time frame: postoperative 18-24 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 NCT01767727, 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 29 Oct 2018.