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

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

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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