Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT03240718
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2017-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Organization:
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:
False
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?: