NCT01619917

Brief Summary

While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our assessing the effects of fractional vascular lasers on burn scars. It has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft). Objective: To determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.

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
26mo 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 Progress86%
Nov 2012Jul 2028

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

14.6 years

First QC Date

June 12, 2012

Last Update Submit

December 3, 2024

Conditions

Keywords

burnscarlaserfractionalvascular

Outcome Measures

Primary Outcomes (1)

  • reduction in scar appearance

    examine with modified Vancouver Scar Scale

    every 3 weeks to 15 weeks

Study Arms (2)

Proximal

ACTIVE COMPARATOR

location of the scar proximal to heart

Device: Fractional Vascular Laser

Distal

EXPERIMENTAL

location of scar distal to heart

Device: Fractional Vascular Laser

Interventions

laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result

DistalProximal

Eligibility Criteria

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

You may qualify if:

  • living in Winnipeg
  • burn scar 6-12 months old
  • Fitzpatrick skin type I-III
  • thermal burn scar on trunk or extremities

You may not qualify if:

  • open wound

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

Condition Hierarchy (Ancestors)

Wounds and InjuriesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • S Logsetty, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Gawaziuk, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

November 1, 2012

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations