Clinical trial NCT06726707: COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis
Official title: COPPER: An Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory Trial, Evaluating the Management of Incontinence-Associated Dermatitis Using Copper Containing Absorbing Incontinence Products
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Incontinence-associated Dermatitis
Keywords: urinary incontinence
fecal incontinence
copper
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Essity Hygiene and Health AB
First posted: 2024-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study adopts an exploratory trial design with an adaptive approach. It is randomized, multicenter, controlled, and double-blinded, with parallel groups and blinded outcome adjudication. The study hypothesis suggests that incontinence products infused with copper-based substances may provide superior stabilization of IAD compared to control products.

The primary objective of the study is to evaluate the effectiveness of absorbing incontinence products containing a copper-based substance in stabilizing incontinence-associated dermatitis (IAD) in adults with moderate to severe urinary and/or fecal incontinence. This will be compared against standard absorbing incontinence products without copper-based substances, with both groups receiving usual care. Secondary objectives include assessing improvements in pain within 14 and 28 days, evaluating quality of life improvements over 28 days, and measuring changes in skin health scores from baseline to 14 and 28 days.

Participants will be adults aged 60 years or older, experiencing moderate to severe urinary and/or fecal incontinence. Eligibility will be determined using specific scales outlined in the study rationale. Recruitment will target individuals in long-term care facilities or hospital wards located within São Paulo municipality and its metropolitan area in Brazil. Feasibility assessments will be conducted at each site during an initial visit. Sites deemed suitable will then proceed with participant recruitment.

This study seeks to address critical aspects of managing IAD, particularly through innovative copper-based products. By focusing on clinical endpoints such as pain reduction, quality of life enhancements, and improvements in skin health, the trial aims to provide evidence supporting the potential benefits of copper-infused incontinence products over traditional alternatives.

Eligibility criteria: Inclusion Criteria:

* Ability and capability to participate in the study and follow study procedures as determined by the investigator.
* With moderate or more intense urinary (ISI ≥ 3) and/or fecal incontinence (Pescatori et al. (B1, B2, B3, C1, C2, C3);
* Current users of absorbing incontinence products.
* Diagnosed with incontinence-associated dermatitis GLOBIAD 1A or 2A.

Exclusion Criteria:

* Incontinence-associated dermatitis GLOBIAD 1B or 2B;
* The subject who knows about allergy or a history of an adverse reaction to product ingredients or to any topical preparations or skincare products;
* The subject who has an active skin condition or a history of recurrent skin conditions, except IAD, that may affect IAD healing;
* The subject who was treated in the previous week with systemic or topical agents (except for IAD) that may affect IAD healing process (e.g., steroids);
* Subject with a score \< 10 in Mini Nutritional Assessment - Short Form;
* Subjects with diabetes.

Primary outcomes:
measure: Proportion of non-progressing IAD 14 days
timeFrame: 14 days
Secondary outcomes:
measure: Proportion of non-progressing IAD 28 days
timeFrame: 28 days
measure: Pain assessment
timeFrame: 14 and 28 days
measure: Quality of life SF12
timeFrame: 28 days
measure: Skin health by skin health assessment tool
timeFrame: 14 and 28 days
measure: Time to resolution of IAD
timeFrame: From enrollment to resolution, mean of 4 to 7 days
measure: Reoccurrence of IAD
timeFrame: From resolution of the first episode of IAD to the 28th day
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Israelita Albert Einstein - ARO
name: Henrique A Rodrigues da Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
References: