MedTrace Logo

COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis

NCT06726707 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2026-01-12

No results posted yet for this study

Summary

As there are currently no evidence on the benefit of absorbing incontinence products with copper to stabilize IAD in the elderly, thus, this study will assess the capacity and safety of an absorbing incontinence products with a copper-based substance for the management of adults with incontinence-associated dermatitis, compared to an absorbing incontinence products with no substance. This approach may contribute for IAD management arsenal, since clinical evidence on the efficiency of products available in the market to manage IAD is frail, as seen in systematic reviews mentioned above. We believe copper, as a barrier product, has the potential to perform well in this clinical setting of IAD, as it performed well in other settings.

Conditions

  • Incontinence-associated Dermatitis

Interventions

COMBINATION_PRODUCT

Diaper with a copper-based product + usual care

The intervention is an incontinence aid product and its performance is related to its ability to absorb and contain urine/ feces as well as keeping the skin dry.

COMBINATION_PRODUCT

Barrier product with common diaper

The common diaper is an incontinence aid and its performance is related to its ability to absorb and contain urine/ feces as well as keeping the skin dry.

Sponsors & Collaborators

  • Essity Hygiene and Health AB

    collaborator INDUSTRY

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Henrique A Rodrigues da Fonseca, PhD · Hospital Israelita Albert Einstein - ARO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-06-30
Completion
2026-08-30

More Related Trials

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 NCT06726707 on ClinicalTrials.gov