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Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis

NCT03298113 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-02

Study results available
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Summary

The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)

Conditions

  • Incontinence-associated Dermatitis

Interventions

DEVICE

Cavilon Advanced Skin Protectant

Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.

DEVICE

IAD Hospital Standard Care

Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Matthew M. Cooper, MD · 3M

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-17
Primary Completion
2018-07-10
Completion
2018-07-10
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298113 on ClinicalTrials.gov