Ignite Creation Date:
2025-12-18 @ 9:11 AM
Ignite Modification Date:
2025-12-18 @ 9:11 AM
Study NCT ID:
NCT02724449
Status:
None
Last Update Posted:
2024-12-17 00:00:00
First Post:
2015-05-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
Sponsor:
None
Organization:
Study Overview
Official Title:
A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
Status:
None
Status Verified Date:
2024-11
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 an open label, non randomized prospective case series evaluating 3M Cavilon Advanced Barrier Film for the treatment of severe incontinence associated dermatitis (IAD) in the presence or absence of continued fecal or fecal and urinary incontinence. The product will be applied twice a week for a maximum duration of 3 weeks. Subjects will be followed twice a week until healing, for a maximum of 3 weeks or earlier, if discharged from the facility. During the study period, the frequency and intensity of their incontinence will be monitored, twice a week photographic documentation and IAD site assessments will be completed.
Detailed Description:
None
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?: