Injury ArmNCT03193983
V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone
A study testing Flaps Coverage and Occlusive Dressing in people with Injury Arm, run by Assiut University at 1 site in Egypt.
Trial summary
Fingertip is a complex structure that is responsible for the fine function of the fingers and the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious condition that if untreated properly could… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Injury Arm
- What is being tested?
- Flaps Coverage and Occlusive Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to May 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- a. Inclusion criteria:
- Age Adults 12 - 60 years
- Diagnosis of fingertip injury with exposed bone (Allen type 2, 3 or 4) in any finger.
- Informed consent obtained by the patient.
Who cannot join
- · Old or complicated fingertip injuries.
- Non-exposed bone fingertip injury (Allen type1).
- Patients with severe debilitating disease.
Trial locations and contacts
1 site in 1 country.
About this study
Fingertip is a complex structure that is responsible for the fine function of the fingers and the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious condition that if untreated properly could lead to significant functional disability and disuse of the injured finger. Up to date, defining the best treatment option for this injury remains controversial. Hand surgeons are divided between proponents of flap coverage and conservative treatment, driven by beliefs, training programs and financial aspects. After recently reviewing the literature for the current best evidence and fundamentals of conservative treatment, Krauss and Lalandei in their recent review of the literature, pointed out to the necessity for implementing controlled trials to compare both ways of treatment.
Read the detailed description
The purpose of this study is to determine the efficacy and the results of occlusive dressing in treating fingertip injuries in comparison to flaps with much concern to certain factors that are closely related to our locality including patient compliance for regular follow up , functional outcome , time to return to work and its socioeconomical impact and cosmetic results .
Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.
Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks
- Conditions
- Injury Arm
- Being tested
- Flaps Coverage, Occlusive Dressing
- Keywords
- occlusive dressing
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaps CoverageProcedure or surgery
Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.
Occlusive DressingProcedure or surgery
Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Flaps Coverage | Experimental | Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks. Receives: Procedure: Flaps Coverage |
| Occlusive Dressing | Experimental | Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks. Receives: Procedure: Occlusive Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
quick DASH score
A questionnaire consisting of eleven items that test the functional recovery following upper limb injury
Measured: 6 months
Secondary outcomes (5)
The presence of nail deformity.
any nail deformity will be reported the most common is hook nail deformity and then the deformity wiil be classified according to the severity to mild moderate and severe
Measured: 6 months
Pulp volume compared to the contralateral finger: on lateral X-ray
either no decrease in the pulp volume or decreased to less than the half compared to the contralateral finger or more than the half compared to the contralateral finger
Measured: 6 months
presence of painful neuroma
absent or present if present either affect patient function or not
Measured: 6 months
Sensory related outcome in the form of Two point discrimination test (Weber index)
measurement and classification of Two point discrimination can be done by Touch-Test 2-Point Discriminator which consists of two sturdy, rotating, plastic disks that are joined together.Rounded tips are spaced at standard testing intervals from 1 to 15 mm apart. A 20 and 25 mm spacing also are given. One disk setting tests from 1 to 8mm, and the other setting tests from 9 to 15 mm. To change settings, just rotate the top disk until it clicks in place
Measured: 6 months
Finger length: expressed as a shortage in mm. compared to contralateral finger.
the shortage is classified to three items a) no shortage b) less half compared to contralateral finger and c) more than compared to contralateral finger
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startJan 2017
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury ArmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks. Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdelnasser Abdelfatah Farghay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193983
- Sponsor's protocol ID
- AssiutUMAAFDD
- Status last verified
- May 2020
- First submitted
- 26 May 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: whole study data and results will be available
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V-Y Flap Versus Occlusive Dressing in Treating Fingertip Injuries With Exposed Bone
- ClinicalTrials.gov ID
- NCT03193983
- Acronym / sponsor ID
- AssiutUMAAFDD
- Conditions
- Injury Arm
- Keywords
- occlusive dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 21 Jun 2017 (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.
Fingertip is a complex structure that is responsible for the fine function of the fingers and the whole hand. A fingertip injury is any soft tissue, nail or bony injury distal to the insertions of the long flexor and extensor tendons of a finger .Fingertip injury is a serious condition that if untreated properly could lead to significant functional disability and disuse of the injured finger. Up to date, defining the best treatment option for this injury remains controversial. Hand surgeons are divided between proponents of flap coverage and conservative treatment, driven by beliefs, training programs and financial aspects. After recently reviewing the literature for the current best evidence and fundamentals of conservative treatment, Krauss and Lalandei in their recent review of the literature, pointed out to the necessity for implementing controlled trials to compare both ways of treatment.
Detailed description
The purpose of this study is to determine the efficacy and the results of occlusive dressing in treating fingertip injuries in comparison to flaps with much concern to certain factors that are closely related to our locality including patient compliance for regular follow up , functional outcome , time to return to work and its socioeconomical impact and cosmetic results .
Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.
Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks. Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Flaps Coverage | Experimental | Procedure: Flaps CoverageSurgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks. |
| Occlusive Dressing | Experimental | Procedure: Occlusive DressingConservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- a. Inclusion criteria:
Key exclusion criteria (3 listed)
- · Old or complicated fingertip injuries.
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 |
|---|---|---|
| Flaps CoverageSurgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks. | Procedure or surgery | Flaps Coverage |
| Occlusive DressingConservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks. | Procedure or surgery | Occlusive Dressing |
Primary outcome
quick DASH score
Time frame: 6 months
A questionnaire consisting of eleven items that test the functional recovery following upper limb injury
5 secondary outcomes
The presence of nail deformity.
Time frame: 6 months
Pulp volume compared to the contralateral finger: on lateral X-ray
Time frame: 6 months
presence of painful neuroma
Time frame: 6 months
Sensory related outcome in the form of Two point discrimination test (Weber index)
Time frame: 6 months
Finger length: expressed as a shortage in mm. compared to contralateral finger.
Time frame: 6 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 12 May 2020.
- Individual participant dataSharing planned: Yes. whole study data and results will be available
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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 Flaps Coverage and Occlusive Dressing in people with Injury Arm, run by Assiut University at 1 site in Egypt.
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 12 May 2020. 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 Egypt. 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?
quick DASH score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2020.