Back to resultsComparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
Primary Purpose
Incontinence-associated Dermatitis
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cavilon Advanced Skin Protectant
IAD Hospital Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Incontinence-associated Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Is the patient 18 years or older?
- Has the patient or their legally authorized representative signed the Informed Consent Form?
- 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?
- Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
- Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
- Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?
Exclusion Criteria:
- Is the patient pregnant or breast feeding?
- Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
- Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
- Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
- Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
- Does the patient have any other local dermatological disease or skin condition interfering with this study?
- 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?
- Does the patient participate in another study with a known or implied effect on skin barrier function?
Sites / Locations
- Universitair Ziekenhuis Gent
- Charité - Universitätsmedizin Berlin
- University Hospital Southampton
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cavilon Advanced Skin Protectant
IAD Hospital Standard Care
Arm Description
Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.
Marketed products are applied according to the IAD hospital standard care routine.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03298113
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence-associated Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Central reader
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cavilon Advanced Skin Protectant
Arm Type
Experimental
Arm Description
Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use.
Arm Title
IAD Hospital Standard Care
Arm Type
Other
Arm Description
Marketed products are applied according to the IAD hospital standard care routine.
Intervention Type
Device
Intervention Name(s)
Cavilon Advanced Skin Protectant
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IAD Hospital Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing of IAD
Description
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.
Time Frame
up to 21 days depending on length of hospitalization
Other Pre-specified Outcome Measures:
Title
Improvement of IAD Category
Description
Number and percentage of patients improved with regard to IAD category
Time Frame
Up to 21 days depending on length of hospitalization
Title
Re-epithelialization of Skin Loss
Description
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).
Time Frame
up to 21 days depending on length of hospitalization
Title
Time to Heal IAD
Description
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)
Time Frame
Up to 21 days depending on length of hospitalization
Title
Time to Improve in IAD Category
Description
Time to improve in IAD category in the terms of days of treatment.
Time Frame
Up to 21 days depending on length of hospitalization
Title
Prevention of Skin Loss
Description
Protection of IAD category 1 patients from developing IAD category 2
Time Frame
up to 21 days depending on length of hospitalization
Title
Prevention of IAD Recurrence
Description
Protection of completely healed patients from recurrence of IAD during the study.
Time Frame
up to 21 days depending on length of hospitalization
Title
Product Cost: IAD 1A
Description
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.
Time Frame
up to 21 days depending on length of hospitalization
Title
Product Cost : IAD 2A
Description
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
Time Frame
up to 21 days depending on length of hospitalization
Title
Use of Resources Involved in IAD Therapy
Description
Additional appointments with specialists involved in IAD therapy
Time Frame
Up to 21 days depending on length of hospitalization
Title
Nursing Time Related to Cleansing
Description
Nursing time to clean up incontinence episode
Time Frame
up to 21 days depending on length of hospitalization
Title
Nursing Time Related to Product Application
Description
Nursing time to administer skin protectants for IAD treatment
Time Frame
up to 21 days depending on length of hospitalization
Title
Pain Related to Cleansing: IAD 1A
Description
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.
Time Frame
up to 21 days depending on length of hospitalization
Title
Pain Related to Cleansing: IAD 2A
Description
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.
Time Frame
up to 21 days depending on length of hospitalization
Title
Pain Related to Product Application: IAD 1A
Description
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.
Time Frame
up to 21 days depending on length of hospitalization
Title
Pain Related to Product Application: IAD 2A
Description
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.
Time Frame
up to 21 days depending on length of hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is the patient 18 years or older?
Has the patient or their legally authorized representative signed the Informed Consent Form?
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?
Is the patient incontinent and does stool and/or urine come into direct contact with the skin?
Is the patient able to be turned/positioned with regard to skin assessment and photo documentation?
Is there a reasonable expectation that the patient will remain in the hospital setting for at least 7 days?
Exclusion Criteria:
Is the patient pregnant or breast feeding?
Does the patient have a known hypersensitivity or allergy to acrylate or cyanoacrylate?
Does the patient have a stage II, III, IV or unstageable pressure ulcer or other suspected deep tissue injury in the study area?
Does the patient require topical treatment due to a fungal, bacterial or viral infection in the study area?
Does the patient require treatment with topical medication or product other than IAD treatment in the study area?
Does the patient have any other local dermatological disease or skin condition interfering with this study?
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?
Does the patient participate in another study with a known or implied effect on skin barrier function?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew M. Cooper, MD
Organizational Affiliation
3M
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Hospital Southampton
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis
We'll reach out to this number within 24 hrs