- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690543
Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
December 29, 2020 updated by: Aiman Naseem, Dow University of Health Sciences
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 50 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:- • Both genders.
- Joints supple.
- Linear contracture bands.
- Age between 5years to 50 years.
- Surrounding non scarred skin.
- Contractures of axilla, cubital fossa, popliteal fossa and digits.
Exclusion Criteria:
Deep burns.
- Joint contractures.
- Surrounding skin scarred.
- Broad, irregular contracture.
- Neck, Perineal, wrist or toe contractures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: z-plasty
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.
|
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.
|
EXPERIMENTAL: square flap
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gain in length
Time Frame: 3 weeks
|
calculation of the gain in length achieved after the release of post burn contrature
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aiman Naseem, DUHS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 1, 2021
Primary Completion (ANTICIPATED)
July 1, 2021
Study Completion (ANTICIPATED)
July 1, 2021
Study Registration Dates
First Submitted
December 25, 2020
First Submitted That Met QC Criteria
December 29, 2020
First Posted (ACTUAL)
December 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 29, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANaseem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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