NCT01488240

Brief Summary

The purpose of this study is to determine the effects (good or bad) of pulsed dye laser treatment in burn scar height, texture, redness and pliability in acute burn injury.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress93%
Nov 2012Jun 2027

First Submitted

Initial submission to the registry

December 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

13.6 years

First QC Date

December 5, 2011

Last Update Submit

December 3, 2024

Conditions

Burn Scar

Keywords

burnscarlaser

Outcome Measures

Primary Outcomes (1)

  • Scar Characteristics

    Examine characteristics of scar

    six months

Study Arms (2)

Proximal

ACTIVE COMPARATOR

part of scar proximal to heart

Procedure: pulsed dye laser

Distal

ACTIVE COMPARATOR

part of scar distal to heart

Procedure: pulsed dye laser

Interventions

pulsed dye laserPROCEDURE

laser energy

DistalProximal

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • burn scar
  • living in Winnipeg
  • scar age one to 6 months
  • Fitzpatrick I-III skin type

You may not qualify if:

  • open wound
  • active infection
  • previous scar treatment with steroid injection or interferon
  • established disposition towards keloid scarring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

BurnsCicatrix

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Wounds and InjuriesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • S Logsetty, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin P Gawaziuk, MSc

CONTACT

2047873669jgawaziuk@hsc.mb.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 8, 2011

Study Start

November 1, 2012

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations

CA(1)