Back to resultsComparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
Primary Purpose
Burn Scar
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
z-plasty
square flap
Sponsored by
About this trial
This is an interventional treatment trial for Burn Scar
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
z-plasty
square flap
Arm Description
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 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.
Outcomes
Primary Outcome Measures
gain in length
calculation of the gain in length achieved after the release of post burn contrature
Secondary Outcome Measures
Full Information
NCT ID
NCT04690543
First Posted
December 25, 2020
Last Updated
December 29, 2020
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04690543
Brief Title
Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
Official Title
Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
z-plasty
Arm Type
Active Comparator
Arm Description
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.
Arm Title
square flap
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
z-plasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
square flap
Intervention Description
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.
Primary Outcome Measure Information:
Title
gain in length
Description
calculation of the gain in length achieved after the release of post burn contrature
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aiman Naseem
Phone
03215621936
Email
aiman.naseem1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Usamah Bin Waheed
Phone
03332774950
Email
usamah_chundrigar@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiman Naseem
Organizational Affiliation
DUHS
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
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