Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03697447
Status:
COMPLETED
Last Update Posted:
2022-11-25
First Post:
2018-03-22
Brief Title:
Endermotherapy With Burn Hypertrophic Scars
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Randomized Controlled Within-patient Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes These proposed changes are meant to induce more pliability so that skin possesses the strength and elasticity required for normal mobility The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue However research documenting and supporting this effect is lacking The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics including erythema pigmentation pliability and thickness in adult burn survivors and their subjective evaluation of itch pain and overall scar outcome through a prospective randomized controlled within-patient single-blinded study
Detailed Description:
Patients will receive 12 weeks of endermotherapy 3 times a week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None