Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release

Sponsor

Dow University of Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04690543

Collaborator

(none)

Enrollment

Arms

4.9

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Burn Scar	Procedure: z-plasty Procedure: square flap	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are assigned to one of two or more groups in parallel for the duration of the studyParticipants are assigned to one of two or more groups in parallel for the duration of the study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

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.	Procedure: 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.
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.	Procedure: 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.

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.

Procedure: z-plasty

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.

Procedure: square flap

Outcome Measures

Primary Outcome Measures

gain in length [3 weeks]
calculation of the gain in length achieved after the release of post burn contrature

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dow University of Health Sciences

Investigators

Principal Investigator: Aiman Naseem, DUHS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aiman Naseem, FCPS trainee, plastic surgery, DUHS, Dow University of Health Sciences

ClinicalTrials.gov Identifier:

NCT04690543

Other Study ID Numbers:

ANaseem

First Posted:

Dec 30, 2020

Last Update Posted:

Dec 30, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Contracture

Burns

Study Results

No Results Posted as of Dec 30, 2020