Finger InjuriesNCT04961879
Dorsal Finger Reconstruction
A study testing Reversed Cross Finger Flap and reversed island homo-digital flap in people with Finger Injuries, run by Sohag University at 1 site in Egypt.
Trial summary
objective of this study is To compare reversed cross finger flap with reversed island homo-digital flap in distal dorsal finger defect reconstruction regarding reliability \& functional and aesthetic outcomes . Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Finger Injuries
- What is being tested?
- Reversed Cross Finger Flap and reversed island homo-digital flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2021to Mar 2022
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with dorsal digital defect distal to distal interphalangeal joint (DIP) joint
- defect size ranged from 1 to 2 cm in width and 1-3 cm in length
Who cannot join
- chronic heavy smokers,
- traumatic injury to the donor site and perforator .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study to Evaluate the Difference Between Reversed Cross Finger Flap Versus Reversed Island Homo-digital Flap in Distal Dorsal Finger Defect Reconstruction
objective of this study is To compare reversed cross finger flap with reversed island homo-digital flap in distal dorsal finger defect reconstruction regarding reliability \& functional and aesthetic outcomes .
comparative study that will be conducted at Plastic surgery department, Sohag university hospital on 30 patients .The population of the study will be patients with distal dorsal digital defects. We will divide the cases into two equal groups: the first are operated with reversed cross-finger flap and the second are operated with reversed island homo-digital flap.
- Conditions
- Finger Injuries
- Being tested
- Reversed Cross Finger Flap, reversed island homo-digital 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.
Reversed Cross Finger FlapProcedure or surgery
distal dorsal finger defect will be reconstructed by reversed cross finger flap
- reversed cross finger flap is a modified cross finger flap harvested from an adjacent finger .
reversed island homo-digital flapProcedure or surgery
distal dorsal finger defect will be reconstructed by reversed island homo-digital flap
- this flap is harvested from the same finger .
| Study group | Role | What they receive |
|---|---|---|
| Reversed Cross Finger Flap group 1 | Active comparator | Not described Receives: Procedure: Reversed Cross Finger Flap |
| Reversed island Homo-digital Flap group 2 | Active comparator | Not described Receives: Procedure: reversed island homo-digital flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in range of motion between group 1 and group 2
difference in range of motion between group 1 and group 2 will be measured by manual goniometer in degrees
Measured: difference in range of motion between group 1 and group 2 will be measured at 4 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start14 Jul 2021
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elhossieny abdelaal mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961879
- Sponsor's protocol ID
- Soh-Med-21-07-09
- Status last verified
- Feb 2022
- First submitted
- 13 Jul 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study to Evaluate the Difference Between Reversed Cross Finger Flap Versus Reversed Island Homo-digital Flap in Distal Dorsal Finger Defect Reconstruction
- ClinicalTrials.gov ID
- NCT04961879
- Acronym / sponsor ID
- Soh-Med-21-07-09
- Conditions
- Finger Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 14 Jul 2021 (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.
objective of this study is To compare reversed cross finger flap with reversed island homo-digital flap in distal dorsal finger defect reconstruction regarding reliability \& functional and aesthetic outcomes .
comparative study that will be conducted at Plastic surgery department, Sohag university hospital on 30 patients .The population of the study will be patients with distal dorsal digital defects. We will divide the cases into two equal groups: the first are operated with reversed cross-finger flap and the second are operated with reversed island homo-digital flap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reversed Cross Finger Flap group 1 | Active comparator | Procedure: Reversed Cross Finger Flap |
| Reversed island Homo-digital Flap group 2 | Active comparator | Procedure: reversed island homo-digital flap |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with dorsal digital defect distal to distal interphalangeal joint (DIP) joint
- defect size ranged from 1 to 2 cm in width and 1-3 cm in length
Key exclusion criteria (2 listed)
- chronic heavy smokers,
- traumatic injury to the donor site and perforator .
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 |
|---|---|---|
| Reversed Cross Finger Flapdistal dorsal finger defect will be reconstructed by reversed cross finger flap - reversed cross finger flap is a modified cross finger flap harvested from an adjacent finger . | Procedure or surgery | Reversed Cross Finger Flap group 1 |
| reversed island homo-digital flapdistal dorsal finger defect will be reconstructed by reversed island homo-digital flap - this flap is harvested from the same finger . | Procedure or surgery | Reversed island Homo-digital Flap group 2 |
Primary outcome
difference in range of motion between group 1 and group 2
Time frame: difference in range of motion between group 1 and group 2 will be measured at 4 months postoperative
difference in range of motion between group 1 and group 2 will be measured by manual goniometer in degrees
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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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 Reversed Cross Finger Flap and reversed island homo-digital flap in people with Finger Injuries, run by Sohag 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. 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?
Results are not available in the source record.
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?
difference in range of motion between group 1 and group 2 (time frame: difference in range of motion between group 1 and group 2 will be measured at 4 months postoperative). 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 17 Feb 2022.