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Barrier Film

Clinical Study to Assess a New Barrier Film's Ability to Provide Skin Protection Against Incontinence & Allow Healing

N/A
Waitlist Available
Research Sponsored by Solventum US LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days depending on length of hospitalization
Awards & highlights
No Placebo-Only Group

Summary

The purpose of the study is to evaluate the safety and efficacy of the investigational product (3M™ Cavilon™ Advanced High Endurance Skin Protectant) for the treatment of incontinence associated dermatitis.

Eligible Conditions
  • Incontinence Associated Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days depending on length of hospitalization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days depending on length of hospitalization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores
Secondary study objectives
Pain Scores During Incontinence Management
Prevention of IAD.
Re-epithelialization to a Category 1 or Lower

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cavilon Advanced Skin ProtectantExperimental Treatment1 Intervention
Product applicator contains liquid barrier applied on buttocks/thighs with it drying rapidly to durable barrier film. It's applied 3x/per week.
Group II: ConvaTec Sensi-Care Protective BarrierActive Control1 Intervention
Marketed product applied following manufacturer's recommendation. The product is 15% zinc oxide with petrolatum.

Find a Location

Who is running the clinical trial?

Solventum US LLCLead Sponsor
64 Previous Clinical Trials
10,389 Total Patients Enrolled
1 Trials studying Incontinence Associated Dermatitis
20 Patients Enrolled for Incontinence Associated Dermatitis
3MIndustry Sponsor
159 Previous Clinical Trials
31,531 Total Patients Enrolled
3 Trials studying Incontinence Associated Dermatitis
611 Patients Enrolled for Incontinence Associated Dermatitis
Pat Parks, MDStudy Director3M
~4 spots leftby Dec 2025
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