Trials / Completed
CompletedNCT02724449
A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Solventum US LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cavilon Advanced Barrier Film | Cavilon Advanced Barrier Fim's application applied twice a week |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2016-03-31
- Last updated
- 2024-12-17
- Results posted
- 2017-06-09
Source: ClinicalTrials.gov record NCT02724449. Inclusion in this directory is not an endorsement.