Clinical trial NCT03298113: Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
Official title: Effects of an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis Compared to Hospital Standard Care Practice: an Exploratory Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incontinence-associated Dermatitis
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2017-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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?

Primary outcomes:
measure: Healing of IAD
timeFrame: up to 21 days depending on length of hospitalization
Secondary outcomes:
Other outcomes:
measure: Improvement of IAD Category
timeFrame: Up to 21 days depending on length of hospitalization
measure: Re-epithelialization of Skin Loss
timeFrame: up to 21 days depending on length of hospitalization
measure: Time to Heal IAD
timeFrame: Up to 21 days depending on length of hospitalization
measure: Time to Improve in IAD Category
timeFrame: Up to 21 days depending on length of hospitalization
measure: Prevention of Skin Loss
timeFrame: up to 21 days depending on length of hospitalization
measure: Prevention of IAD Recurrence
timeFrame: up to 21 days depending on length of hospitalization
measure: Product Cost: IAD 1A
timeFrame: up to 21 days depending on length of hospitalization
measure: Product Cost : IAD 2A
timeFrame: up to 21 days depending on length of hospitalization
measure: Use of Resources Involved in IAD Therapy
timeFrame: Up to 21 days depending on length of hospitalization
measure: Nursing Time Related to Cleansing
timeFrame: up to 21 days depending on length of hospitalization
measure: Nursing Time Related to Product Application
timeFrame: up to 21 days depending on length of hospitalization
measure: Pain Related to Cleansing: IAD 1A
timeFrame: up to 21 days depending on length of hospitalization
measure: Pain Related to Cleansing: IAD 2A
timeFrame: up to 21 days depending on length of hospitalization
measure: Pain Related to Product Application: IAD 1A
timeFrame: up to 21 days depending on length of hospitalization
measure: Pain Related to Product Application: IAD 2A
timeFrame: up to 21 days depending on length of hospitalization
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: East Flanders
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: 3M
name: Matthew M. Cooper, MD
role: STUDY_DIRECTOR
References: