Ignite Creation Date:
2024-05-06 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03240718
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2017-02-03
Brief Title:
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Randomized Controlled Within-patient Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled within-patient single-blinded pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars The studied primary outcomes of treatment are scar pliability thickness vascularity pain itch and patient satisfaction
Detailed Description:
Prior to treatment initiation two independent scars sites will be selected and an anatomically- on each individual At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart The scar sites will be evaluated at baseline immediately before the 3rd treatment and 12 weeks after their final treatment session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None