Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05429411
Status:
RECRUITING
Last Update Posted:
2023-07-11
First Post:
2022-06-02
Brief Title:
Nonsilicone Gel Sheet for 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 Study to Evaluate the Efficacy of a Nonsilicone Gel Sheet for the Treatment of Hypertrophic Scar in Adult Burn Survivors
Status:
RECRUITING
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:
Overview The application of gel sheets holds promise for both the prevention and treatment of hypertrophic scar after deep dermal injuries Although some positive results have been published a Cochrane review of the data concluded that the trials were of poor quality therefore only provided weak evidence for their benefit One of the limitations of previous studies has been the subjectivity and potential bias of the evaluation tools that were used The validation of electronic instrumentation for the measurement of hypertrophic scar and determination of their superior clinometric properties provides the basis from which precise systematic evaluations can now be performed that will allow for confident conclusions to be made Thus the objective of this study is to evaluate the efficacy of a non-silicone gel sheet relative to a patient-matched control site in a prospective randomized controlled within-patient study This study has been piloted and the data used to establish the number of participants that will be required for an adequately powered study
Specific Objectives
1 To characterize the changes in vascularity thickness pain and itch in adult burn hypertrophic scar HSc following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars
2 To characterize the changes in pliability of adult burn HSc following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars
Recruitment Burn survivors aged 14 years and more who have developed HSc and are being treated at CHUM and Villa Medica Rehabilitation Hospital
Risks There is a minimal risk that the gel used in this project might cause minor redness 10-25 if the use instructions are not followed The rash quickly resolves once the gel sheet is removed
Study Site This study will be carried out at Villa Medica Rehabilitation Hospital
Specific Objectives
1 To characterize the changes in vascularity thickness pain and itch in adult burn hypertrophic scar HSc following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars
2 To characterize the changes in pliability of adult burn HSc following an extended course of treatment with a non-silicone based gel sheet relative to matched control scars
Recruitment Burn survivors aged 14 years and more who have developed HSc and are being treated at CHUM and Villa Medica Rehabilitation Hospital
Risks There is a minimal risk that the gel used in this project might cause minor redness 10-25 if the use instructions are not followed The rash quickly resolves once the gel sheet is removed
Study Site This study will be carried out at Villa Medica Rehabilitation Hospital
Detailed Description:
Participants will wear the gels for 4 hours for the first 2 days 8 hours for the second 2 days with a gradual increase of at least 2 hoursday until they reach 21 hoursday Once the graduate progression has been completed the gel sheet will be applied daily by the subjects for as close to 21 hours as possible
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