Trial Outcomes & Findings for Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis (NCT NCT03298113)

NCT ID: NCT03298113

Last Updated: 2024-12-02

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: up to 21 days depending on length of hospitalization
• Results posted on: 2024-12-02

Participant Flow

Participant milestones

Measure	Cavilon Advanced Skin Protectant Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care Marketed products are applied according to the IAD hospital standard care routine. 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.
Overall Study STARTED	10	10
Overall Study IAD 1A	3	4
Overall Study IAD 2A	7	6
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cavilon Advanced Skin Protectant n=10 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Age, Categorical >=65 years	8 Participants n=10 Participants	10 Participants n=10 Participants	18 Participants n=20 Participants
Sex: Female, Male Female	8 Participants n=10 Participants	5 Participants n=10 Participants	13 Participants n=20 Participants
Sex: Female, Male Male	2 Participants n=10 Participants	5 Participants n=10 Participants	7 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	4 participants n=10 Participants	4 participants n=10 Participants	8 participants n=20 Participants
Region of Enrollment Germany	6 participants n=10 Participants	6 participants n=10 Participants	12 participants n=20 Participants

PRIMARY outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the intention-to-treat (ITT) population.

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.

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=10 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Healing of IAD Not completely healed	10 Participants	9 Participants
Healing of IAD Completely healed	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 21 days depending on length of hospitalization

Population: Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (IAD 2A: skin loss without clinical signs of infection) and switched to IAD 1A (IAD 1A: persistent redness without clinical signs of infection).

Number and percentage of patients improved with regard to IAD category

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=10 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Improvement of IAD Category Worsened	0 Participants	0 Participants
Improvement of IAD Category Remained the Same	8 Participants	8 Participants
Improvement of IAD Category Improved	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the IAD 2A patient population at start of study (IAD 2A: skin loss without clinical signs of infection)

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).

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=7 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=6 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Re-epithelialization of Skin Loss Not completely ephitelialized	5 Participants	4 Participants
Re-epithelialization of Skin Loss Completely epithelialized	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 21 days depending on length of hospitalization

Population: Analysis was done based on the intention-to-treat (ITT) population. No healing event occured in the arm/group treated with Cavilon Advanced Skin Protectant in this study.

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)

Outcome measures

Measure	Cavilon Advanced Skin Protectant Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=1 Healing Events Marketed products are applied according to the IAD hospital standard care routine. 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.
Time to Heal IAD	—	13.00 Days

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 21 days depending on length of hospitalization

Population: Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (skin loss without clinical signs of infection) and switched to IAD 1A (persistent redness without clinical signs of infection).

Time to improve in IAD category in the terms of days of treatment.

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=2 Improvement Events Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=2 Improvement Events Marketed products are applied according to the IAD hospital standard care routine. 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.
Time to Improve in IAD Category	9.50 Days Standard Deviation 0.707	5.50 Days Standard Deviation 2.121

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the IAD 1A patient population at start of study (IAD 1A: persistent redness without clinical signs of infection)

Protection of IAD category 1 patients from developing IAD category 2

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=3 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=4 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Prevention of Skin Loss Improved	0 Participants	0 Participants
Prevention of Skin Loss Worsened	0 Participants	0 Participants
Prevention of Skin Loss Remained the Same	3 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: The overall number of participants analyzed represents the number of patients completely healed during this study. No healing event occured in the group treated with Cavilon Advanced Skin Protectant and therefore prevention of IAD recurrence could no be assessed. One healing event occured in the group treated with IAD Hospital Standard Care.

Protection of completely healed patients from recurrence of IAD during the study.

Outcome measures

Measure	Cavilon Advanced Skin Protectant Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=1 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Prevention of IAD Recurrence	—	0 IAD Recurrence Events

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the IAD 1A population at start of study (IAD1A: persistent redness without clinical signs of infection).

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.

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=3 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=4 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Product Cost: IAD 1A	5.56 Euro Standard Deviation 3.80	0.75 Euro Standard Deviation 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the IAD 2A population at start of study (IAD 2A: Skin loss without clinical signs of infection)

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

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=7 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=6 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Product Cost : IAD 2A	4.67 Euro Standard Deviation 2.53	1.21 Euro Standard Deviation 1.34

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 21 days depending on length of hospitalization

Population: Analysis was done based on the intention-to-treat (ITT) population

Additional appointments with specialists involved in IAD therapy

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=10 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Use of Resources Involved in IAD Therapy	0 Appointments	0 Appointments

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the intention-to-treat (ITT) population Note: One patient allocated to Cavilon Advanced Skin Protectant participated in the study for only one day. Therefore, the time required to clean up the incontinence episode could not be measured (n = 1 missing data set; only 9 data sets were available for analysis).

Nursing time to clean up incontinence episode

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=9 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Nursing Time Related to Cleansing	13.67 Minutes Standard Deviation 7.99	12.41 Minutes Standard Deviation 8.17

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the intention-to-treat (ITT) population Note: For two patients allocated to Cavilon Advanced Skin Protectant the nursing time to administer the skin protectant was not recorded (n = 2 missing data sets; only 8 data sets were available for analysis).

Nursing time to administer skin protectants for IAD treatment

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=8 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Nursing Time Related to Product Application	2.49 Minutes Standard Deviation 3.20	2.02 Minutes Standard Deviation 1.90

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the IAD 1A study population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set; only n = 3 data sets were available for analysis)

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.

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=3 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=3 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Pain Related to Cleansing: IAD 1A	0.00 Change in score on a scale Standard Deviation 0.000	-2.00 Change in score on a scale Standard Deviation 3.464

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient allocated to Cavilon Advanced Skin Protectant was not able to report pain (n = 1 missing data set; only n = 6 data sets were available for analysis)

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.

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=6 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=6 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Pain Related to Cleansing: IAD 2A	-3.00 Change in score on a scale Standard Deviation 4.147	-0.33 Change in score on a scale Standard Deviation 4.274

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on the IAD 1A population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set, only n= 3 data sets were available for analysis)

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.

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=3 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=3 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Pain Related to Product Application: IAD 1A	0.00 Change in score on a scale Standard Deviation 0.000	0.00 Change in score on a scale Standard Deviation 0.000

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 21 days depending on length of hospitalization

Population: Analysis was done based on IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient in the Cavilon Advanced Skin Protectant group and one patient in the IAD Hospital Standard care group were not able to report pain.

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.

Outcome measures

Measure	Cavilon Advanced Skin Protectant n=6 Participants Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=5 Participants Marketed products are applied according to the IAD hospital standard care routine. 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.
Pain Related to Product Application: IAD 2A	-2.33 Change in score on a scale Standard Deviation 4.082	-1.20 Change in score on a scale Standard Deviation 5.020

Adverse Events

Cavilon Advanced Skin Protectant

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

IAD Hospital Standard Care

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Cavilon Advanced Skin Protectant n=10 participants at risk Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 participants at risk Marketed products are applied according to the IAD hospital standard care routine. 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.
Cardiac disorders Cardiac arrest	10.0% 1/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)	0.00% 0/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)
Renal and urinary disorders Acute renal failure	0.00% 0/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)	10.0% 1/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)

Other adverse events

Measure	Cavilon Advanced Skin Protectant n=10 participants at risk Product applicator contains liquid barrier and is applied according to the 3M manufacturer's instructions for use. 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.	IAD Hospital Standard Care n=10 participants at risk Marketed products are applied according to the IAD hospital standard care routine. 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.
Infections and infestations Fungal infection	20.0% 2/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)	20.0% 2/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)
Infections and infestations Clostridium difficile infection	10.0% 1/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)	0.00% 0/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)
Infections and infestations Bacterial infection	10.0% 1/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)	0.00% 0/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)
Product Issues Device adhesion issue	10.0% 1/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)	0.00% 0/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)
Infections and infestations Vaginal mycosis	10.0% 1/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)	0.00% 0/10 • 9 months ISO 14155 Definitions (ISO: International Organization for Standardization)

Additional Information

Nancy Klinger, Clinical Manager

3M Healthcare Business Group

Phone: 651 736

Email: nmklinger@mmm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place