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

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

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

Number and percentage of patients improved with regard to IAD category

Time frame: 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).

Nursing time to clean up incontinence episode

Time frame: 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 administer skin protectants for IAD treatment

Time frame: 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).

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

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 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

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 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

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 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

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.

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

Time frame: 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 IAD category 1 patients from developing IAD category 2

Time frame: 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)

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

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 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

Population: Analysis was done based on the IAD 2A 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).

Time frame: 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)

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

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

Time frame: 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).

Additional appointments with specialists involved in IAD therapy

Time frame: Up to 21 days depending on length of hospitalization

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