Burn ScarNCT04690543
Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
A study testing z-plasty and square flap in people with Burn Scar, run by Dow University of Health Sciences.
Trial summary
the purpose of this study is to compare the gain in length after postburn contracture release using two different techniques, the more commonly practised z - plasty and relatively newer technique, square flap Read more about this study
- Who is it for?
- Ages 5 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Scar
- What is being tested?
- z-plasty and square flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Jul 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Joints supple.
- Linear contracture bands.
- Age between 5years to 50 years.
- Surrounding non scarred skin.
- Contractures of axilla, cubital fossa, popliteal fossa and digits.
Who cannot join
- Deep burns.
- Joint contractures.
- Surrounding skin scarred.
- Broad, irregular contracture.
- Neck, Perineal, wrist or toe contractures
Trial locations and contacts
No sites are listed yet.
About this study
the purpose of this study is to compare the gain in length after postburn contracture release using two different techniques, the more commonly practised z - plasty and relatively newer technique, square flap
- Conditions
- Burn Scar
- Being tested
- z-plasty, square flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
z-plastyProcedure or surgery
Z-plasty: It will be defined as a local transposition flap that will be used to improve the functional and cosmetic appearance of scars. It will be involved creating two triangular flaps of equal dimensions that will be transposed.
square flapProcedure or surgery
Square flap: It will be defined as is another local transposition flap which will be used for release of contractures. Square will be marked on one side of the contracture, and two triangles will be marked on the other side, with the length of all the flaps equal, which will be then transposed.
| Study group | Role | What they receive |
|---|---|---|
| z-plasty | Active comparator | Z-plasty: It will be defined as a local transposition flap that will be used to improve the functional and cosmetic appearance of scars. It will be involved creating two triangular flaps of equal dimensions that will be transposed. Receives: Procedure: z-plasty |
| square flap | Experimental | Square flap: It will be defined as is another local transposition flap which will be used for release of contractures. Square will be marked on one side of the contracture, and two triangles will be marked on the other side, with the length of all the flaps equal, which will be then transposed. Receives: Procedure: square flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
gain in length
calculation of the gain in length achieved after the release of post burn contrature
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study startFeb 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies 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
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiman Naseem, Dow University of Health Sciences
- Investigators
- Aiman Naseem, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690543
- Sponsor's protocol ID
- ANaseem
- Status last verified
- Dec 2020
- First submitted
- 25 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
- ClinicalTrials.gov ID
- NCT04690543
- Acronym / sponsor ID
- ANaseem
- Conditions
- Burn Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 30 Dec 2020 (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.
the purpose of this study is to compare the gain in length after postburn contracture release using two different techniques, the more commonly practised z - plasty and relatively newer technique, square flap
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| z-plasty | Active comparator | Procedure: z-plastyZ-plasty: It will be defined as a local transposition flap that will be used to improve the functional and cosmetic appearance of scars. It will be involved creating two triangular flaps of equal dimensions that will be transposed. |
| square flap | Experimental | Procedure: square flapSquare flap: It will be defined as is another local transposition flap which will be used for release of contractures. Square will be marked on one side of the contracture, and two triangles will be marked on the other side, with the length of all the flaps equal, which will be then transposed. |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Joints supple.
- Linear contracture bands.
- Age between 5years to 50 years.
- Surrounding non scarred skin.
- Contractures of axilla, cubital fossa, popliteal fossa and digits.
Key exclusion criteria (5 listed)
- Deep burns.
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 |
|---|---|---|
| z-plastyZ-plasty: It will be defined as a local transposition flap that will be used to improve the functional and cosmetic appearance of scars. It will be involved creating two triangular flaps of equal dimensions that will be transposed. | Procedure or surgery | z-plasty |
| square flapSquare flap: It will be defined as is another local transposition flap which will be used for release of contractures. Square will be marked on one side of the contracture, and two triangles will be marked on the other side, with the length of all the flaps equal, which will be then transposed. | Procedure or surgery | square flap |
Primary outcome
gain in length
Time frame: 3 weeks
calculation of the gain in length achieved after the release of post burn contrature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Aiman Naseem principal investigator
DUHS
Questions about this trial
What is this clinical trial studying?
A study testing z-plasty and square flap in people with Burn Scar, run by Dow University of Health Sciences.
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 5 inclusion and 5 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Aiman Naseem (03215621936, aiman.naseem1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gain in length (time frame: 3 weeks). 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 30 Dec 2020.