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

Solventum US LLC

Status: Terminated

Conditions: Incontinence-associated Dermatitis

Treatments: Device: IAD Hospital Standard Care; Device: Cavilon Advanced Skin Protectant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03298113

CLIN-PROT-EU-05-293312

Details and patient eligibility

About

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)

Full description

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). IAD is a skin damage caused by exposure to moisture and irritants such as urine and/or stool. The clinical appearance ranges from painful erythema to severe erosion and denudation/skin loss with or without secondary infection. The durable, long lasting skin protectant (3M study device) is formulated to attach to moist or wet skin surfaces (i.e., superficial, partial thickness skin loss) to provide better protection against moisture and irritants under challenging conditions.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Is the patient 18 years or older?
2. Has the patient or their legally authorized representative signed the Informed Consent Form?
3. Does the patient have IAD category 1A (IAD 1A: persistent redness without clinical signs of infection) or IAD category 2A (IAD 2A: skin loss without clinical signs of infection) in the study area (study area: the sacral region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold?
4. Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
5. Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
6. Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?

Exclusion criteria

1. Is the patient pregnant or breast feeding?
2. Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
3. Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
4. Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
5. Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
6. Does the patient have any other local dermatological disease or skin condition interfering with this study?
7. Does the patient have any medical condition (e.g. end of life, planned elective surgery) that in the opinion of the investigator should exclude him/her from participating in the study?
8. Does the patient participate in another study with a known or implied effect on skin barrier function?

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Cavilon Advanced Skin Protectant

Experimental group

Description:

Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.

Treatment:

Device: Cavilon Advanced Skin Protectant

IAD Hospital Standard Care

Other group

Description:

Marketed products are applied according to the IAD hospital standard care routine.

Treatment:

Device: IAD Hospital Standard Care