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

Effects of an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis Compared to Hospital Standard Care Practice: an Exploratory Randomized Controlled Trial

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)

Study Overview

• Status: Terminated
• Conditions: Incontinence-associated Dermatitis
• Intervention / Treatment: Device: Cavilon Advanced Skin Protectant; Device: IAD Hospital Standard Care

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • East Flanders
    • Gent, East Flanders, Belgium, 9000
      • Universitair Ziekenhuis Gent
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
• United Kingdom
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cavilon Advanced Skin Protectant; Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.	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.
Other: IAD Hospital Standard Care; Marketed products are applied according to the IAD hospital standard care routine.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing of IAD	Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool) Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is "other pre-specified". The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital.	up to 21 days depending on length of hospitalization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of IAD Category	Number and percentage of patients improved with regard to IAD category	Up to 21 days depending on length of hospitalization
Re-epithelialization of Skin Loss	Number and percentage of patients with 100% re-epithelialization of skin loss based on structured skin assessment (skin loss: skin is moist, as the epidermal layer is missing).	up to 21 days depending on length of hospitalization
Time to Heal IAD	Time to complete healing of IAD in the terms of days of treatment (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)	Up to 21 days depending on length of hospitalization
Time to Improve in IAD Category	Time to improve in IAD category in the terms of days of treatment.	Up to 21 days depending on length of hospitalization
Prevention of Skin Loss	Protection of IAD category 1 patients from developing IAD category 2	up to 21 days depending on length of hospitalization
Prevention of IAD Recurrence	Protection of completely healed patients from recurrence of IAD during the study.	up to 21 days depending on length of hospitalization
Product Cost: IAD 1A	Mean average daily product cost per patient for IAD 1A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment. Note: One patient in the group treated with Cavilon Advanced Skin Protectant stayed only one day in the study due to an unrelated Severe Adverse Event at night. This had an impact on the product cost calculation. The application interval for Cavilon Advanced Skin Protectant in this study was three days (D1, D4, D7, D10, D13, D16, D19) , while the use of IAD products for standard hospital care was based on manufacturer recommendations, which could correspond to a daily interval with multiple applications.	up to 21 days depending on length of hospitalization
Product Cost : IAD 2A	Mean average daily cost per patient for IAD 2A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment	up to 21 days depending on length of hospitalization
Use of Resources Involved in IAD Therapy	Additional appointments with specialists involved in IAD therapy	Up to 21 days depending on length of hospitalization
Nursing Time Related to Cleansing	Nursing time to clean up incontinence episode	up to 21 days depending on length of hospitalization
Nursing Time Related to Product Application	Nursing time to administer skin protectants for IAD treatment	up to 21 days depending on length of hospitalization
Pain Related to Cleansing: IAD 1A	Pain scores related to clean up incontinence episode for IAD 1A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain. For cleansing, IAD 1A patients treated with Cavilon Advanced Skin Protectant saw no change in pain due to having no pain reported at baseline nor last visit. Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patients able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2, 4, 6, 8, 10), with higher score indicating more pain.	up to 21 days depending on length of hospitalization
Pain Related to Cleansing: IAD 2A	Pain scores related to clean up incontinence episode for IAD 2A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain. Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.	up to 21 days depending on length of hospitalization
Pain Related to Product Application: IAD 1A	Pain scores related to application of skin protectants for IAD 1A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline. Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.	up to 21 days depending on length of hospitalization
Pain Related to Product Application: IAD 2A	Pain scores related to application of skin protectants for IAD 2A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline. More extreme negative values denote a larger reduction in pain. Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain.	up to 21 days depending on length of hospitalization

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Study Director: Matthew M. Cooper, MD, 3M

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): July 10, 2018
• Study Completion (Actual): July 10, 2018

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Physiological Effects of Drugs; Protective Agents
• Other Study ID Numbers: CLIN-PROT-EU-05-293312

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes