NCT04690543

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 25, 2020

Last Update Submit

December 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • gain in length

    calculation of the gain in length achieved after the release of post burn contrature

    3 weeks

Study Arms (2)

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.

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.

Procedure: square flap

Interventions

z-plastyPROCEDURE

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
square flapPROCEDURE

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

Eligibility Criteria

Age5 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Joints supple.
  • Linear contracture bands.
  • Age between 5years to 50 years.
  • Surrounding non scarred skin.
  • Contractures of axilla, cubital fossa, popliteal fossa and digits.

You may not qualify if:

  • Deep burns.
  • Joint contractures.
  • Surrounding skin scarred.
  • Broad, irregular contracture.
  • Neck, Perineal, wrist or toe contractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Aiman Naseem

    DUHS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FCPS trainee, plastic surgery, DUHS

Study Record Dates

First Submitted

December 25, 2020

First Posted

December 30, 2020

Study Start

February 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share