Effects of an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis Compared to Hospital Standard Care Practice: an Exploratory Randomized Controlled Trial
Phase: NA
Conditions: Incontinence-associated Dermatitis
Sponsor: Solventum US LLC

  
 
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Clinical Investigational Plan / 
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Clinical Study  
 
Title of the Clinical 
Study  
 
 
Effects of an advanced skin protectant in the management of 
incontinence-associated dermatitis compared to hospital standard care 
practice: an exploratory randomized controlled trial 
 
Coordinating 
Investigator 
Jan Kottner, PhD 
Priv.-Doz. Dr. rer. curae   
Charité – Universitätsmedizin Berlin  
Department of Dermatology and Allergy  
Clinical Research Center for Hair and Skin Science  
Charitéplatz 1 
10117 Berlin 
Germany   
Telephone: +49 30 450 518 218 
FAX: + 49 30 450 518 952 
Email: Jan.Kottner@charite.de 
Web: http://www.crcberlin.com; http://www.derma.charite.de 
 
Investigators 
United Kingdom 
 
David Voegeli, PhD, BSc, RN, FHEA 
Associate Professor of Nursing  
Skin Health Research Group 
Faculty of Health Sciences 
University of Southampton 
A Level South Academic Block (MP11) 
University Hospital Southampton 
Southampton  
SO16 6YD 
United Kingdom  
Telephone: +44 23 8120 3162 
Email: D.Voegeli@soton.ac.uk 
Web: http://www.southampton.ac.uk/namrip 
 
Co-Investigator: 
Lisette Schoonhoven, PhD, FEANS 
Professor of Nursing  
Faculty of Health Sciences 
University of Southampton 
A Level South Academic Block (MP11) 
Southampton General Hospital 
Tremona Road  
Southampton  
SO16 6YD 
United Kingdom 
Telephone: +44 2381 208 644 
Email: L.Schoonhoven@soton.ac.uk 
Web: http://www.southampton.ac.uk  
 
 
 

  
 
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Investigator 
Belgium  
Hilde Beele, PhD 
Professor of Dermatology 
Universitair Ziekenhuis Gent 
De Pintelaan 185  
9000 Gent  
Belgium 
Telephone: +32 9332 33 81 
Email: Hilde.Beele@uzgent.be 
Web: http://www.uzgent.be 
Co-Investigator (Researcher): 
Dimitri Beeckman, RN, PhD 
Professor of Nursing  
University Centre for Nursing and Midwifery  
UZ Gent – 5K3 
De Pintelaan 185 
9000 Gent   
Belgium  
Telephone: +32 9332 8348 
Email: Dimitri.Beeckman@UGent.be 
Web: http://www.UCVVGent.be  
 
Investigator 
Germany  
Annika Vogt, PhD 
Priv.-Doz. Dr. med. 
Charité – Universitätsmedizin Berlin 
Department of Dermatology and Allergy  
Clinical Research Center for Hair and Skin Science 
Charitéplatz 1 
10117 Berlin  
Germany  
Telephone: +49 30 450 618 208 
Email: annika.vogt@charité.de 
Web: http://www.crcberlin.com; http://www.derma.charite.de 
 
Blinded Assessor 
Photography 
Dimitri Beeckman, RN, PhD 
Professor of Nursing  
University Centre for Nursing and Midwifery  
UZ Gent – 5K3 
De Pintelaan 185 
9000 Gent   
Belgium  
Telephone: +32 9332 8348 
Email: Dimitri.Beeckman@UGent.be 
Web: http://www.UCVVGent.be 
 
 
 
 
 
 

  
 
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Sponsor  
3M Deutschland GmbH 
Carl-Schurz-Str. 1 
41453 Neuss 
Germany 
Web: http://www.3mdeutschland.de 
 
3M Biostatistician 
Bruce Ekholm 
Manager, Clinical Research & Senior Biostatistical Specialist 
Health Care Business 
3M Center, 270-3A-04 
St. Paul, MN 55144-1000 
USA  
Telephone: +1 651 736 0657 
 
FAX: +1 651 7334931 
Email: bpekholm@mmm.com 
Web: http://www.3m.com 
 
3M Monitor 
Alexandra Dreuw  
3M Deutschland GmbH 
Carl-Schurz-Str. 1 
41453 Neuss 
Germany 
Telephone: +49 2131 14 3094 
FAX: +49 2131 14 123094 
Email: adreuw@mmm.com 
Web: http://www.3mdeutschland.de 
 
 
3M Medical 
Monitor  
Jens Bichel, Dr. med.  
3M Deutschland GmbH 
Carl-Schurz-Str. 1 
41453 Neuss 
Germany 
Telephone: +49 2131 144674 
FAX: +49 2131 14 124674 
Email: jbichel@mmm.com 
Web: http://www.3mdeutschland.de 
 
 
CRO  
acromion GmbH  
Europaallee 27-29 
50226 Frechen 
Germany 
Telephone: +49 2234 203737 0 
FAX: +49 2234 203737 9 
Web: http://www.acromiongmbh.com/ 
 
 
 

  
 
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Approver List (3M Approvers Only): 
 
 
Signer 
Role 
Date Signed 
xxxxxxxxxxxxxxxxxxxxxxxxxxx 
Clinical 
January 30, 2018  02:06:51  AM CST 
xxxxxxxxxxxxxxxxxxxxxxxxxxx 
Clinical 
January 29, 2018  10:38:52  AM CST 
xxxxxxxxxxxxxxxxxxxxxxxxxxx 
Clinical 
January 30, 2018  03:01:46  AM CST 
xxxxxxxxxxxxxxxxxxxxxxxxxxx 
Regulatory 
January 30, 2018  07:29:50  AM CST  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3M Confidential 
This document contains confidential information that is the property of 3M and is patient to all of 
the restrictions on use and disclosure contained in the study contract to which this is appended. 
Do not copy, disclose, circulate or use for benefit for any third party without written authorization 
from 3M.  
 
 
 
 
 

  
 
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Clinical Investigational Plan / 
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Table of Contents 
 
1. 
OVERALL SYNOPSIS ......................................................................................................................... 9 
2. 
BACKGROUND INFORMATION ....................................................................................................... 13 
2.1 Identification and description of the study device ....................................................................... 15 
2.1.1 
Summary description of the study device ..................................................................... 15 
2.1.2 
Intended purpose and intended purpose in the clinical investigation ........................... 15 
2.1.3 
Population and indication study device is intended ...................................................... 16 
2.1.4 
Summary of necessary training .................................................................................... 16 
2.1.5 
Traceability and labeling ............................................................................................... 16 
2.1.6 
Other material labeling .................................................................................................. 16 
3. 
JUSTIFICATION OF THE DESIGN OF THE CLINICAL INVESTIGATION ...................................... 16 
4. 
RISK AND BENEFITS OF THE STUDY DEVICE AND CLINICAL INVESTIGATION ...................... 17 
4.1 Anticipated clinical benefits ......................................................................................................... 17 
4.2 Anticipated adverse device effects. ............................................................................................ 17 
4.3 Residual risks associated with the study device ......................................................................... 17 
4.4 Risks associated with participation in the clinical investigation. ................................................. 18 
4.5 Possible interactions with concomitant medical treatments. ...................................................... 18 
4.6 Steps that will be taken to control or mitigate the risks............................................................... 19 
4.7 Risk-to-benefit rationale .............................................................................................................. 19 
5. 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION ..................................... 20 
5.1 Objectives ................................................................................................................................... 20 
5.2 Hypothesis .................................................................................................................................. 20 
5.3 Claims and intended performance .............................................................................................. 20 
5.4 Anticipated risks and adverse device effects .............................................................................. 20 
6. 
STATISTICAL CONSIDERATION ..................................................................................................... 21 
6.1 Statistical design, method and analytical procedures ................................................................. 21 
6.2 Sample size ................................................................................................................................ 21 
6.3 Level of significance and power .................................................................................................. 22 
6.4 Expected drop-out rate ............................................................................................................... 22 
6.5 Pass/Fail criteria ......................................................................................................................... 22 
6.6 Provision for interim analysis (if applicable) ............................................................................... 22 
6.7 Termination criteria ..................................................................................................................... 22 
6.8 Deviations ................................................................................................................................... 23 
6.9 Subgroup specification ............................................................................................................... 23 
6.10 Procedures that take into account all the data ........................................................................... 23 
6.11 Procedures for accounting missing, unused or spurious data .................................................... 23 
6.12 Patient calculation per center ..................................................................................................... 23 
7. 
DESIGN OF THE CLINICAL INVESTIGATION ................................................................................. 23 
7.1 Clinical investigational type ......................................................................................................... 23 
7.2 Randomization and blinding ....................................................................................................... 24 
7.3 Endpoints .................................................................................................................................... 24 
7.4 Methods and timing for assessing, recording and analysing variables ...................................... 25 
7.5 Equipment ................................................................................................................................... 28 

  
 
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7.6 Replacement of patients ............................................................................................................. 29 
8. 
STUDY DEVICE(S) AND COMPARATOR(S) .................................................................................... 29 
8.1 Description of the exposure ........................................................................................................ 29 
8.2 Number of study devices ............................................................................................................ 29 
8.3 Justification of the choice of comparator(s) ................................................................................ 29 
8.4 Other medical device or medication ........................................................................................... 29 
8.5 Regulatory requirements of study material ................................................................................. 29 
9. 
PATIENTS .......................................................................................................................................... 30 
9.1 Inclusion criteria .......................................................................................................................... 30 
9.2 Exclusion criteria ......................................................................................................................... 30 
9.3 Criteria and procedures for patient withdrawal or discontinuation .............................................. 31 
9.4 Point of enrolment ....................................................................................................................... 31 
9.5 Total expected duration .............................................................................................................. 31 
9.6 Expected duration of each patient’s participation ....................................................................... 31 
9.7 Number of patients required ....................................................................................................... 32 
9.8 Enrolment period......................................................................................................................... 33 
10. TREATMENT OF PATIENTS ............................................................................................................. 33 
11. ASSESSMENT OF EFFECTS/PERFORMANCE .............................................................................. 34 
11.1 Effect/performance parameters .................................................................................................. 34 
11.2 Assessment method ................................................................................................................... 35 
12. MONITORING ..................................................................................................................................... 40 
12.1 Source data ................................................................................................................................. 40 
13. DATA MANAGEMENT ....................................................................................................................... 41 
13.1 Data review, database cleaning, data query management ........................................................ 41 
13.2 Verification, validation and securing of eDC system .................................................................. 42 
13.3 Data retention and archiving ....................................................................................................... 42 
13.4 Notification requirements and time frames ................................................................................. 43 
13.5 Corrective and preventive actions and principal investigator disqualification criteria ................. 43 
13.6 Other aspects of clinical quality assurance ................................................................................ 43 
14. DEVIATIONS FROM CLINICAL INVESTIGATION PLAN ................................................................ 43 
14.1 Amendments ............................................................................................................................... 43 
14.2 Protocol Deviations ..................................................................................................................... 44 
15. DEVICE ACCOUNTABILITY.............................................................................................................. 44 
16. STATEMENT OF COMPLIANCE ....................................................................................................... 44 
17. INFORMED CONSENT PROCESS ................................................................................................... 45 
17.1 Special circumstances for informed consent .............................................................................. 45 
17.1.1 
Patient needing legally authorized representatives ................................................. 45 
17.1.2 
Patient unable to read or write ................................................................................. 45 
18. ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES ...................... 46 
18.1 Assessment of safety .................................................................................................................. 46 
18.1.1 
Safety parameters .................................................................................................... 47 

  
 
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18.1.2 
Assessment of methods ........................................................................................... 47 
18.2 Foreseeable adverse events and anticipated adverse device effects ........................................ 48 
18.3 Definitions ................................................................................................................................... 48 
18.4 Reporting and timelines .............................................................................................................. 50 
18.4.1 
Reportable events .................................................................................................... 50 
18.4.2 
Report by whom ....................................................................................................... 50 
18.4.3 
Report to whom ........................................................................................................ 51 
18.4.4 
Report by the investigator to the sponsor ................................................................ 51 
18.4.5 
Reporting form .......................................................................................................... 51 
18.5 Emergency contact details .......................................................................................................... 52 
18.6 Drug Monitoring Committee ........................................................................................................ 52 
19. SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION............... 52 
20. PUBLICATION POLICY ..................................................................................................................... 52 
21. DATA HANDLING AND RECORD KEEPING ................................................................................... 52 
21.1 Site personal ............................................................................................................................... 52 
21.2 Pre-clinical investigation documentation requirements .............................................................. 53 
21.3 Completion and return of case report forms ............................................................................... 53 
22. FINAL REPORT ................................................................................................................................. 53 
23. BIBLIOGRAPHY ................................................................................................................................ 54 
24. APPENDIX .......................................................................................................................................... 56 
24.1 Clinical investigational schedule ................................................................................................. 57 
24.2 Ghent Global IAD Categorization Tool ....................................................................................... 59 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
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Abbreviations 
 
AE 
Adverse Event 
ADE  
Adverse Device Effect  
eCRF 
Electronic Case Report Form 
CRO  
Contract Research Organization 
EC 
Ethics Committee 
eDC 
Electronic Data Capture 
EEC 
European Economic Community 
EPUAP 
European Pressure Ulcer Advisory Panel  
FDA  
Food And Drug Administration 
GCP 
Good Clinical Practice 
GLOBIAD  
Ghent Global IAD Categorization Tool  
IAD 
Incontinence-Associated Dermatitis 
ISO 
International Organization for Standardization 
IC  
Informed Consent  
IFU  
Instructions For Use  
NPUAP 
National Pressure Ulcer Advisory Panel 
n 
Number 
p 
Probabiltiy 
PU 
Pressure Ulcer  
RCT  
Randomized Controlled Trial  
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis System 
SOP 
Standard Operating Procedure  
UK 
United Kingdom  
USA  
United States of America 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
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1. 
Overall synopsis 
 
Study 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 
 
Sponsor 
3M Deutschland GmbH 
Carl-Schurz-Str. 1 
41453 Neuss  
Germany 
  
Study Design 
Exploratory, randomized, controlled, multi-center, multi-country 
 
Study Device & 
Regulatory Status  
3MTM CavilonTM Advanced Skin Protectant  
 
CE-marked medical device class IIa according to the Medical Device 
Directive 93/42/EEC, Annex IX, rule 4 
 
Comparator 
Local hospital IAD care regime (IAD care products and procedures)  
 
Study Objective(s) & 
Hypothesis 
The intention of the study is to assess the effects of 3M Cavilon Advanced 
Skin Protectant in comparison to different local IAD care regimes in hospitals. 
The study is designed as an exploratory study to learn more about the effect 
size of certain variables such as healing outcome when compared to different 
local IAD care regimes and will consider the medical routine of Western 
European hospitals regarding IAD care under real-world circumstances.  
 
Due to the exploratory design no formal a priori hypothesis is defined. The 
results of the study will be used to examine the feasibility of a potential 
subsequent confirmatory RCT. 
 
Study Endpoints 
3M Cavilon Advanced Skin Protectant compared to local hospital IAD  
care  
 
• 
Number and percentage of patients completely healed  
(skin free of any IAD signs, including erythema) 
• 
Number and percentage of patients improved with regard to IAD 
category 
• 
Number and percentage of patients with 100% re-epithelialization of 
skin loss (skin loss: skin is moist, as the epidermal layer is missing) 
• 
Time to complete healing or reduction in IAD category 
• 
Protection of IAD category 1 patients from developing IAD category 2  
• 
Prevention with regard to IAD recurrence   
• 
Material cost based on product utilization such as type of products, 
frequency of application and days of treatment 
• 
Use of resources involved in the IAD therapy 
• 
Nursing time to clean up incontinence and to administer IAD 
treatment products 
• 
Pain scores with regard to cleansing procedure and application of 
IAD product (Wong-Baker FACES® Pain Rating Scale: assessment 
only for cognitively healthy patients according to the judgement of the 
study nurse) 
• 
Number and percentage of patients with adverse events and the 
nature of each adverse event as defined for this study 
 

  
 
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Study Population 
Hospitalized incontinent patients with IAD category 1A or 2A according to the 
Ghent Global IAD Categorization Tool (GLOBIAD). 
   
IAD category 1A: Persistent redness without clinical signs of infection 
IAD category 2A: Skin loss without clinical signs of infection  
 
Study Area  
Study Area: 
The study area is defined as the sacral region going down to the upper 
thighs, bordered approximately 5 cm below the gluteal fold. The study area 
is to be photographed on Day 01 and every three days until the end of the 
study (Day 04, 07 … Day 21). Additional photos are to be taken at the first 
day no evidence of IAD is present (transition from IAD1 to IAD free) and if 
applicable, on the first day of 100% re-epithelialization of skin loss (transition 
from IAD2 to IAD1). The central reader will conduct a blinded skin 
assessment based on the photo documentation of the study area on Day 01, 
first day(s) of transition to an improved IAD category and on the last day of 
patient’s study participation. 
 
 
 Study Area: IAD has to be present in this zone 
 
Skin Assessment:  
The patient’s skin will be  assessed daily for IAD signs in the study area and  
additionally the navel to upper thigh region according to the GLOBIAD 
criteria.  Futhermore, an estimate will be provided for the total affected IAD 
area including signs of erythema and in addition with focus on skin loss only, 
if applicable.   
 
  
 Skin Assessment Areas: Back Side & Front  
 
Product Application:   
Cavilon Advanced Skin Protectant will be applied to the study area that is 
defined as the sacral region going down to the upper thighs, bordered 
approximately 5 cm below the gluteal fold (IAD affected as well as unaffected 
skin). The genital area and the frontal skin folds will be treated only in case of 
visible IAD and only for the IAD affected skin. In consideration of the 
manufacturer’s instruction for use no topical medication or other product shall 
be applied on top of the barrier film because the effectiveness of either film or 
medication might be reduced. The hospital standard care products of the 
comparator group will be applied to the skin areas following the local hospital 
ward procedures and considering the manufacturers’ instructions for use 
especially with regard to contraindications. The use of topical medication or 
product other than the IAD treatment is not allowed for the study area in the 
comparator group.  
 
 
 
 

  
 
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Inclusion Criteria 
Patients may be enrolled into this study if the answers to all these questions 
are yes. 
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 or IAD category 2A in the 
study area? 
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 
Patients are excluded from participation in this study if any of the answers to 
these questions are yes.  
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 the 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?  
 
Withdrawal Criteria  
The following withdrawal/discontinuation criteria are defined for the study: 
1. Patient develops a stage III, IV or unstageable pressure ulcer or any 
    other deep tissue injury in the study area  
2. Patient develops a fungal, bacterial or viral infection or other condition 
    requiring the use of topical medication or product in the 
    area treated with IAD products  
3. Patient develops any condition which, in the opinion of the Investigator, 
    requires discontinuation from the study including pregnancy 
 
Period of Patient’s 
Participation 
21 days in maximum 
  
Sample Size  
Due to the exploratory design no formal a priori hypothesis is defined. The 
intention is to learn more about the effect size of certain variables such as 
healing outcome when compared to different local IAD care regimes in 
hospitals. The results of the study will be used to examine the feasibility of a 
potential subsequent confirmatory RCT. 
 
 
 

  
 
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Total: n = 60 patients  
 
Stratum 1: n = 30 IAD 1A patients  
                 (persistent redness without clinical signs of infection) 
                  
Stratum 2: n = 30 IAD 2A patients  
                  (skin loss without clinical signs of infection)  
 
The patients will be allocated 1:1 to either Cavilon Advanced Skin Protectant 
or hospital IAD standard care.  
 
Each site is expected to recruit 10 IAD 1A and 10 IAD 2A patients: 
5 IAD 1A patients allocated to Cavilon Advanced Skin Protectant 
5 IAD 1A patients allocated to hospital IAD care 
5 IAD 2A patients allocated to Cavilon Advanced Skin Protectant 
5 IAD 2A patients allocated to hospital IAD care  
 
Randomization 
Stratified randomization with regard to different IAD categories: 
Stratum 1:  IAD 1A (50% of the patients)  
Stratum 2:  IAD 2A (50% of the patients) 
 
The patients will be allocated 1:1 to either Cavilon Advanced Skin Protectant 
or hospital IAD standard care  
 
Geography 
United Kingdom, Germany, Belgium 
 
# Sites 
3 sites (1 in UK, 1 in Germany, 1 in Belgium) 
 
 # patients per site: 
20 patients per site (10 IAD 1A patients and 10 IAD 2A patients)                        
 
Depending on the recruitment rate the sponsor reserves the right to allow for 
competitive recruitment or to add additional sites. Each site includes at least 
10 patients. 
 
Study Length  
10 months including an enrollment period of 9 months.  
 
Data Analysis Planned  Intention-to-treat analysis (performance/safety) 
Per-protocol analysis (performance) 
All quantitative data will be summarized with descriptive statistics. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
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2. 
Background information 
 
 
Incontinence-associated dermatitis is defined as skin damage caused by exposure to urine and/or 
stool [1]. The clinical appearance ranges from painful erythema to severe erosion and 
denudation/skin loss with or without secondary infection. IAD is a type of irritative contact dermatitis 
triggered by increased skin surface moisture, irritants from urine and feces (e.g. digestive enzymes), 
increased skin temperature (e.g. due to occlusive diapers), and repeated cleansing activities. An 
increased load of intestinal bacteria on the skin surface in combination with skin maceration have 
been shown to contribute to more severe forms of IAD [2]. 
 
 
IAD is a common problem in healthcare settings and can be difficult to treat. Studies have estimated 
prevalence rates from 5.6% to 50% [3-7] and incidence rates between 3.4% – 25% [8-10] depending 
on the type of setting and population studied. Patients in intensive care units and elderly patients are 
considered to be at a particular high risk. IAD and pressure ulcers have a number of risk factors in 
common. Both conditions are most likely to occur in patients who have poor health and problems 
with mobility [11, 12, 13]. A frequent complication of patients with IAD are secondary skin infections, 
candidiasis being one of the most common secondary infections associated with IAD [7].  
 
 
The type of incontinence and frequency of episodes (especially fecal) belong to the key risk factors 
for IAD. Clinicians generally agree that fecal incontinence puts the skin at higher risk for damage 
than exposure to urine alone [6, 14, 15]. This is due to the presence of high levels of lipid- and 
protein-digestive enzymes attacking the stratum corneum. The highest risk of skin damage is linked 
to liquid feces (diarrhea) with extraordinary high levels of digestive enzymes [16,17]. Double 
incontinence with combination of urine and feces can aggravate the condition. The enzymes can 
also act on urea and produce ammonia, further increasing the pH to the optimum of enzyme activity 
[18]. Poor skin condition (e.g. due to aging/steroid use/diabetes), compromised mobility, critical 
illness, medications (antibiotics, immunosuppressants), pain, poor nutritional status, diminished 
cognitive awareness  and inability to perform personal hygiene are further risk factors as well as 
raised body temperature (pyrexia) and the use of occlusive containment products [3, 5, 16, 19, 20]. 
 
 
The problem of IAD receives increasing attention worldwide. Best practice principles for IAD 
prevention and management strategies were published in 2015 by a global expert panel [1]. Based 
on differential IAD diagnosis and considering the individual causes and risk factors the 
comprehensive care plans follow two principles: avoiding contact of urine and/or stool to the skin, 
and providing a structured skin care regimen. The therapy usually starts with the choice of 
appropriate device for fluid management. Adult briefs, absorbent pads and diapers are frequently 

  
 
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used for fluid management but might hold the moisture against the skin if occlusive. Therefore newer 
products with improved fluid handling properties should be considered as an adjunct to a structured 
skin care regimen. Patients in acute settings may require temporary diversion of urine and/or faces 
away from the skin to allow adequate skin protection and/or healing. Indwelling urinary catheter are 
used to avoid contact of urine to the skin but are often linked to a higher risk of nosocomial infection. 
While fecal management systems are used with increasing frequency to contain and divert liquid 
feces from the perineal skin (21, 22, 23), exposure can still occur due to device leakage. 
Consequently, a structured skin care regimen remains a critical consideration. 
 
 
A structured skin care regime consists of two key interventions: gentle cleansing of the skin to 
remove urine and/or feces and protecting the skin to avoid or minimize exposure to urine and/or 
feces and friction. No-rinse skin cleansers with a pH similar to normal skin or pre-moistened 
incontinence care wipes are recommended for gentle cleansing followed by the application of skin 
protectants to build up a barrier between the stratum corneum and any moisture or irritant. A wide 
range of creams, ointments, pastes, lotions and films are available based on different skin barrier 
formulations such as petrolatum-based, dimethicone-based, zinc oxide-based, or liquid film-forming 
acrylate [24]. However, severe IAD with weeping denudement remains difficult to treat because most 
skin barrier products cannot stick to weepy skin and have to be applied as a thick layer on top of the 
wound. In some cases of severe IAD wound dressings that promote moist wound healing are used 
even though the application is challenged by skin contours such as folds and creases, and the 
presence of moisture. 
 
In this study the effects of 3MTM CavilonTM Advanced Skin Protectant regarding IAD management 
and outcome will be assessed in comparison to hospital standard care practice in Western Europe.  
The CE-marked medical device is designed for the use on conditions involving partial-thickness skin 
loss such as severe IAD and  to attach to intact as well as denuded, weepy skin. The liquid is based 
on a new cyanoacrylate chemistry designed to polymerize in situ. Upon application to skin, the liquid 
dries rapidly to form a breathable highly durable film barrier able to protect the skin surface from 
external irritants such as feces [25]. It is elastomeric, adhering to contours of the skin that are 
difficult to dress. The product was tested in care settings of the United States and in comparison to 
United States IAD standard care. The study is designed as an exploratory study to find out the effect 
size of certain screening variables such as healing outcome when compared to the  
different local IAD care regimes and will consider the medical routine of Western European hospitals 
regarding IAD care under real-world circumstances.  
 

  
 
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2.1 
Identification and description of the study device 
 
2.1.1 
Summary description of the study device 
 
 3M™ Cavilon™ Advanced Skin Protectant is 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. It is 
elastomeric, adhering to the contours of the skin and providing a uniform film. The film is 
transparent and possesses good oxygen and moisture vapor permeability. The polymer-
cyanoacrylate is dispersed in a non-stinging solvent. The film is colorless, non-cytotoxic 
and has a low dermatitis potential. The film adheres to dry, moist or wet skin surfaces 
(i.e., superficial, partial thickness skin loss) and remains intact during conditions of 
continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin 
and does not require removal. 
Ingredients: Hexamethyldisiloxane, Acrylic Tetrapolymer, 2-Octyl Cyanoacrylate  
 
 
3M™ Cavilon™ Advanced Skin Protectant is a CE-marked class IIa medical device 
according to the Medical Device Directive 93/42/EEC, Annex IX, rule 4. 
 
2.1.2 
Intended purpose and intended purpose in the clinical investigation 
 
 
Cavilon Advanced Skin Protectant forms a film barrier intended to cover and protect 
intact or damaged skin.  It is effective in conditions where wet and/or dry skin is frequently 
or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, 
wound drainage and urine. The protective film barrier reduces pain associated with 
Incontinence-Associated Dermatitis and prevents, stops, and/or reverses the effects of 
IAD. Cavilon Advanced Skin Protectant also can be used in areas exposed to friction and 
shear from bedding, clothing, shoes or any other material that would rub against the skin 
allowing/enabling the skin to heal.  
 
In this study the effects of Cavilon Advanced Skin Protectant will be assessed regarding 
the treatment of IAD category 1A (persistent redness without clinical signs of infection) 
and IAD category 2A (skin loss without clinical signs of infection). 
 
 
 
 

  
 
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2.1.3 
Population and indication study device is intended 
 
 
 
Cavilon Advanced Skin Protectant is intended for the treatment of Incontinence-  
 
 
associated dermatitis and will be used within its intended use in this study. The study  
 
 
population is characterized by hospitalized incontinent patients with IAD category 1A   
 
 
(persistent redness without clinical signs of infection) or IAD category 2A (skin loss  
 
 
without  clinical signs of infection). 
2.1.4 
Summary of necessary training 
 
The study nurses will be trained with regard to accurate IAD skin assessment and 
 
product application of Cavilon Advanced Skin Protectant according to the manufacturer’s 
 
instructions for use. In addition the study nurses will receive a training with regard to 
 
digital photography and all necessary study documentation.  
2.1.5 
Traceability and labeling 
 
 
 
Cavilon Advanced Skin Protectant bears the CE-Mark and is labeled accordingly. The  
 
 
study supplies will be delivered in their original sales packaging to the sites. Traceability  
 
 
is ensured by the indication of the lot numbers. 
2.1.6 
Other material labeling 
 
 
Not applicable  
 
 
3. 
Justification of the design of the clinical investigation 
 
This study is an exploratory RCT to assess the effects of Cavilon Advanced Skin Protectant in 
comparison to the local IAD care regimes of Western European hospitals. Due to the exploratory 
design no formal a priori hypothesis is defined. The intention is to learn more about the effect size of 
certain variables such as healing outcome when compared to different local IAD care regimes in 
hospitals. The results of the study will be used to examine the feasibility of a potential subsequent 
confirmatory RCT. 
 
 
 

  
 
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4. 
Risk and benefits of the study device and clinical investigation 
 
4.1 
Anticipated clinical benefits 
 
Cavilon Advanced Skin Protectant forms a film barrier intended to cover and protect intact or 
damaged skin. It is effective in conditions where wet and/or dry skin is frequently or 
continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound 
drainage and urine. The protective film barrier reduces pain associated with Incontinence-
Associated Dermatitis and prevents, stops, and/or reverses the effects of IAD. One intention 
of this study is to assess if IAD patients treated with Cavilon Advanced Skin Protectant 
achieve a better and/or faster healing outcome in comparison to patients treated with the 
local IAD care regime of the hospital.  
 
4.2 
Anticipated adverse device effects. 
 
According to the warnings described in the manufacturer’s Instructions for Use the use of 
Cavilon Advanced Skin Protectant on individuals who are allergic to any of the ingredients 
should be avoided. An anticipated adverse device effect is therefore an allergic reaction to 
Cavilon Advanced Skin Protectant. 
 
4.3 
Residual risks associated with the study device 
 
The following contraindications and warnings are described in the manufacturer’s 
Instructions for Use. 
 
Contraindications:  
 
Cavilon Advanced Skin Protectant is NOT to be used: 
• 
as a wound dressing for full thickness wounds 
• 
in or around the eyes 
 
Warnings:  
1. DANGER! HIGHLY FLAMMABLE!  
2. Cavilon Advanced Skin Protectant is highly flammable until it has completely dried on 
 
the skin.  
3. The product should only be applied when no ignition sources or heat-producing devices 
 
are in use.  
4. Avoid using the product around flames. 

  
 
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5. Use the product only in well ventilated areas. 
6. Avoid use on individuals who are allergic to any of the ingredients. 
7. The product is individually packaged for single use only. Reuse could result in increased 
 
risk of infection, or inadequate product performance.  
8. The product is not intended for applications requiring sterile product (e.g. infusion 
 
catheter site protection and care, or surgical site protection). 
9. Keep out of the reach of children. 
 
4.4 
Risks associated with participation in the clinical investigation. 
 
The potential risks associated with participation in the clinical study are considered to be 
similar  with those risks associated with other IAD skin protectant products used for the 
treatment of IAD in the hospital routine. According to the manufacturer’s Instructions for Use 
one potential risk could be an allergic reaction to any of the ingredients of Cavilon Advanced 
Skin Protectant. The liquid of Cavilon Advanced Skin Protectant is highly flammable and 
care should be taken not to apply the product in the presence of heat-emitting devices or 
open flames (e.g. candle) until the barrier film has dried.  
 
4.5 
Possible interactions with concomitant medical treatments. 
 
The following precautions with regard to concomitant medical treatments are described in 
the manufacturer’s Instruction for Use:  
 
Precautions:  
 
• 
Skin absorption and the effectiveness of topical medications (including: antimicrobials, 
 
antifungals, and analgesics) may be reduced or prevented by the presence of the Cavilon 
 
Advanced Skin Protectant.  
• 
Use of other barrier products, ointments, creams or lotions may significantly reduce the 
 
effectiveness of the product. 
• 
The product can increase the adhesion of some adhesive products (e.g. tape), 
 
particularly in the first few days of use. When removing an adhesive product, it is 
 
important to exercise care and follow the Instructions for Use. 
 
 
 

  
 
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4.6 
Steps that will be taken to control or mitigate the risks. 
 
The following steps will be taken to control or mitigate the risks:  
 
• 
All investigators are selected with regard to their profound expertise regarding IAD 
management.  
• 
Research study nurses will be trained on the manufacturer’s Instruction for Use. 
• 
Specific inclusion/exclusion criteria are defined to enroll appropriate patients 
• 
The skin of the patients will be assessed daily during the study  
 
 
Risks are minimized at the clinical site through: 
• 
Compliance with the manufacturer’s Instruction for Use 
• 
Compliance with this study protocol  
• 
Close monitoring of the patient's status during study participation  
 
 
4.7 
Risk-to-benefit rationale 
 
Cavilon Advanced Skin Protectant was tested in an open label, non-randomized prospective 
study in the United States (ClinicalTrials.gov. Identifier: NCT02724449; publication free text 
available [32]). The purpose of the study was to evaluate the efficacy of Cavilon Advanced 
Skin Protectant at managing severe skin breakdown associated with incontinence. The 
sample comprised 16 patients; inclusion criteria were: patients older than 18 years, cared for 
in the intensive care unit of a level I trauma center hospital or in long-term care facilities in 
the northeast region of the United States, and had incontinence-associated dermatitis (IAD). 
Twelve of the patients had epidermal skin loss and 4 had severe redness. The IAD score 
improved in 13 of 16 patients, remained unchanged in 1 patient, and deteriorated in 2 
patients. The median percent improvement in the skin assessment instrument was 96% (p = 
.013). Four of the patients with epidermal skin loss had complete reepithelialization of the 
skin surface with 4 to 6 applications of the skin protectant, and 5 had substantial 
improvement. The 4 patients with severe red skin returned to healthy normal skin with 2 to 4 
skin protectant applications. Substantial pain reduction was reported by all 9 patients who 
reported pain at enrollment. No adverse events associated with the skin protectant 
application were reported during data collection.  
The product is currently tested against zinc oxide paste in a randomized controlled trial in the 
United States (ClinicalTrials.gov Identifier: NCT02570139). 

  
 
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Based on the reported clinical data it is concluded that the product meets the claims 
according to the manufacturer’s Instructions for Use, and that potential undesirable clinical 
effects and risks can be controlled and are acceptable, when weighed against the benefits of 
IAD therapy. 
 
 
5. 
Objectives and hypotheses of the clinical investigation 
 
5.1 
Objectives 
 
 
The objective of the study is to assess the effects of 3M Cavilon Advanced Skin Protectant in 
comparison to the local IAD care regimes of Western European hospitals. Due to the 
exploratory design of the study the objectives are not divided into primary and secondary 
objectives. The study is designed as an exploratory study to learn more about the effect size 
of certain variables such as healing outcome when compared to different local IAD care 
regimes and will consider the medical routine of Western European hospitals regarding IAD 
care under real-world circumstances. Due to the exploratory design no formal a priori 
hypothesis is defined. The results of the study will be used to examine the feasibility of a 
potential subsequent confirmatory RCT.  
 
5.2 
Hypothesis 
 
The study is of exploratory design and no formal a priori hypothesis is defined. 
 
 
5.3 
Claims and intended performance 
 
The claims and intended performance described in the manufacturer’s Instructions for Use 
were supported with laboratory and clinical data generated in the United States. This study 
will test the product performance under the medical routine of European hospitals. The 
performance will be compared to local IAD management regimes.   
 
5.4 
Anticipated risks and adverse device effects  
 
According to the warnings described in the manufacturer’s Instructions for Use an allergic 
reaction to Cavilon Advanced Skin Protectant would constitute an anticipated adverse event 
in this study. 
 

  
 
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6. 
Statistical consideration 
 
6.1 
Statistical design, method and analytical procedures 
 
This study is designed as an exploratory RCT to measure possible effects of Cavilon 
Advanced Skin Protectant in the management of IAD when compared to local IAD care 
regimes (please refer to the study endpoints for more details). The treatment will be 
integrated into the daily medical routine of the hospitals to assess the effects in comparison 
to the local IAD care under real-world circumstances.  
All quantitative data such as demographics, IAD history, IAD skin assessments, pain 
assessments will be summarized with descriptive statistics. In general continuous variables 
will be summarized using the following standard descriptive summary statistics: number of 
observations, arithmetic mean, standard deviation, minimum, median, maximum. Categorical 
variables will be displayed by means of frequency tables and, where appropriate, shift tables.  
The statistical analyses will be based on analysis sets defined as follows: 
 
Full analysis set including safety: 
The full/safety analysis set will include all patients enrolled 
 
Per-protocol analysis set: 
The per-protocol analysis set – being a subset of the full analysis set – will only include 
patients who complete treatment of at least five days. Additionally, patients with major 
protocol violations which may have an impact on efficacy evaluation will be excluded from 
the per-protocol analysis set. 
The determination of major protocol violations which may have an impact on the statistical 
analyses and the resulting definition of analysis sets will be performed prior to start of any  
statistical analyses. A summary of the number of patients per analysis set will be given and 
reasons for exclusion of a patient from an analysis set will be listed. 
The statistical analysis will be performed using the software package SAS® version 9.3 or 
higher (SAS Institute Inc., Cary, NC 27513, USA).  
 
6.2 
Sample size 
 
Due to the exploratory design no formal a priori hypothesis is defined. The intention is to 
learn more about the effect size of certain variables such as healing outcome when 

  
 
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compared to different local IAD care regimes in hospitals. The results of the study will be 
used to examine the feasibility of a potential subsequent confirmatory RCT. 
Total: n = 60 patients  
Stratum 1: n = 30 IAD 1A patients 
                       (persistent redness without clinical signs of infection) 
Stratum 2: n = 30 IAD 2A patients 
                       (skin loss without clinical signs of infection) 
 
The patients will be allocated 1:1 to either Cavilon Advanced Skin Protectant or hospital IAD 
standard care regime. 
Each site is expected to recruit 10 IAD 1A and 10 IAD 2A patients for the study: 
5 IAD 1A patients allocated to Cavilon Advanced Skin Protectant 
5 IAD 1A patients allocated to hospital IAD care 
5 IAD 2A patients allocated to Cavilon Advanced Skin Protectant 
5 IAD 2A patients allocated to hospital IAD care  
 
6.3 
Level of significance and power 
 
 
Not applicable  
 
6.4 
Expected drop-out rate 
 
The sample size of 60 patients includes an anticipated drop-out rate of 20%.  
 
6.5 
Pass/Fail criteria 
 
Not applicable  
 
6.6 
Provision for interim analysis (if applicable) 
 
Not applicable  
 
6.7 
Termination criteria 
 
Termination criteria for the study are described under chapter 19.  
 
 
 
 
 

  
 
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6.8 
Deviations 
 
A statistical analysis plan will be prepared for the study. The statistical analysis plan will 
becompleted before data lock. Any deviation(s) from the statistical analysis plan will be 
described and justified in the final report.  
 
6.9 
Subgroup specification 
 
Subgroups are specified with regard to different IAD severity categories. 
IAD category 1A: persistent redness without clinical signs of infection  
IAD category 2A: skin loss without clinical signs of infection  
 
6.10 Procedures that take into account all the data 
 
All data will be presented in individual patient data listings. 
  
 
6.11 Procedures for accounting missing, unused or spurious data 
 
Missing critical data about effects such as first time observation for 100% re-epithelialization 
of skin loss and complete healing of IAD without any signs of erythema will be imputed. 
Patients excluded from any subset or per protocol analysis will be documented and justified. 
 
6.12 Patient calculation per center 
 
Each center is expected to recruit 20 eligible patients for the study (n = 10 IAD 1A patients;  
n = 10 IAD 2A patients). Depending on the recruitment rate the sponsor reserves the right to 
allow for competitive recruitment or to add additional centers. Each center includes at least 
10 patients. 
 
7. 
Design of the clinical investigation 
 
7.1 
Clinical investigational type 
 
This is a multi-centre, multi-country, prospective, randomized controlled trial. 
CE-marked study device will be used within the intended use according to the manufacturer’s 
Instructions for Use.  
 

  
 
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7.2 
Randomization and blinding 
 
The random numbers will be generated by computer. The randomization is stratified with 
respect to two different IAD severity categories according to the Ghent Global IAD 
Categorization Tool [33; appendix 24.2]. Stratum 1 is defined as IAD category 1A (persistent 
redness without clinical signs of infection) and Stratum 2 as IAD category 2A (skin loss 
without clinical signs of infection). The strata are of same sizes (50:50 ratio). The participants 
will receive either Cavilon Advanced Skin Protectant or the local hospital IAD care products 
within the same stratum. Due to the obvious differences between the comparative hospital 
IAD care prodcuts and the study device, the study nurses cannot be blinded. A blinded 
assessor will assess the healing outcome based on the photographs of the study area that is 
defined as the sacral region going down to the upper thighs, bordered approximately 5 cm 
below the gluteal fold.  
 
7.3 
Endpoints 
 
Due to the exploratory design of the study the endpoints are not divided into primary and 
secondary endpoints. 
The following endpoints are defined for the study with regards to the comparison of Cavilon 
Advanced Skin Protectant  and local IAD hospital care: 
1. Number and percentage of patients completely healed  
(skin free of any IAD signs, including erythema) 
2. Number and percentage of patients improved with regard to IAD category 
3. Number and percentage of patients with 100% re-epithelialization of skin loss 
(skin loss: skin is moist, as the epidermal layer is missing) 
4. Time to complete healing or reduction in IAD category  
5. Protection of IAD category 1 patients from developing IAD category 2   
6. Prevention with regard to IAD recurrence  
7. Material cost based on product utilization such as type of products, frequency of 
application and days of treatment 
8. Use of resources involved in the IAD therapy  
9. Nursing time to clean up incontinence and to administer IAD treatment products 
10. Pain scores with regard to cleansing procedure and application of IAD product 
(Wong-Baker FACES® Pain Rating Scale: assessment only for cognitively healthy 
patients according to the judgement of the study nurse)  

  
 
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11. Number and percentage of patients with adverse events and the nature of each 
adverse event 
 
7.4 
Methods and timing for assessing, recording and analysing variables 
 
Appendix 24.1 presents the study schedule with timing (Flowchart). The assessment 
methods with instructions are described in detail under chapter 11. 
Informed consent shall be obtained in writing from the patient or patient’s legally authorized 
representative and the process shall be documented before any procedure specific to the 
study is applied to the patient. Informed consent may be given by the legally authorized 
representative only if a patient is unable to make the decision to participate in the study (e.g. 
seriously ill or unconscious patient, mentally ill person, mentally handicapped person). In 
such cases, the patient shall also be informed about the study within his/her ability to 
understand.  
 
 
Study Schedule: Day 01 
1. Review the inclusion and exclusion criteria 
2. Randomize the patient to the allocation group (3M study device or hospital IAD standard 
care) 
3. Complete patient demographics (gender, age, height, weight, main reason for 
hospitalization) 
4. Record IAD history (date of IAD diagnosis if known, IAD status, IAD occurrence 
first/recurrent, incontinence type, comorbidities) 
5. Obtain current concomitant medication  
6. Capture information with regard to the Barthel Index  
7. Complete the Braden Scale for Predicting Pressure Sore Risk  
8. Perform skin cleansing  
9. Ask the patient to indicate the IAD pain level before and during cleansing using the 
Wong-Baker FACES® Pain Rating Scale (assessment only for cognitively healthy 
patients according to the judgement of the study nurse)   
10. Perform a structured IAD skin assessment according to the GLOBIAD Tool. Estimate the 
IAD affected area in cm2 using the measurement sheet provided by the sponsor (either of 
the total affected IAD area inclusive signs of erythema or with focus on skin loss only). Fill 
out the IAD study diary with regard to skin assessment information. 

  
 
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11. Take  photographs of the study area according to the site procedure manual. Upload the 
photographs into the photo database. 
12. Depending on the randomization allocation apply Cavilon Advanced Skin Protectant or 
the IAD hospital standard care product 
13. Ask the patient to indicate the IAD pain level before, during and after the application of 
Cavilon Advanced Skin Protectant or the IAD hospital standard care product using the 
Wong-Baker FACES® Pain Rating Scale (assessment only for cognitively healthy 
patients according to the judgement of the study nurse). Document observations 
regarding weeping/exuding and bleeding after product application. 
14. Track IAD care information over the day/night and fill out the IAD study diary 
(incontinence status, use of urinary catheter, use of fecal management system, frequency 
of absorbent pad or diaper changes, frequency of intimate cleansing procedures, 
application frequency of IAD care products, IAD specialist appointments/visits) 
15. Capture detailed information with regard to the use of certain IAD care products in the 
study such as cleansing products, skin protectants building up the moisture barrier, IAD 
wound dressings or other products if applicable [product name, treatment duration period, 
product type, manufacturer, REF number (indicates the manufacturer’s catalogue number 
so that the medical device can be identified), packaging unit, number of containments 
used for the study]  
16. Record adverse events, if applicable  
17. Record protocol deviations, if applicable  
 
      Study Schedule: Day 02 – Day 20 
1. Perform skin cleansing  
2. Day 04, Day 07, Day 10, Day 13, Day 16, Day 19, End of Study (discontinuation):  
Ask the patient to indicate the IAD pain level before and during cleansing using the 
Wong-Baker FACES® Pain Rating Scale (assessment only for cognitively healthy 
patients according to the judgement of the study nurse). 
3. Day 04 IAD Nursing Time: Measure the time taken to clean up incontinence (front/back) 
and the time taken to administer the IAD treatment products to the study area that is 
defined as the sacral region going down to the upper thighs, bordered approximately 5 
cm below the gluteal fold (patients assigned to Cavilon Advanced Skin Protectant  and 
patients assigned to the local hospital IAD care regime). Please consider the nursing time 
measurement instructions (stopwatch and scale provided by the sponsor). Measure the 

  
 
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weight of the skin protectant building up the moisture barrier before and after application if 
the patient is assigned to the local hospital IAD care regime group. 
4. Perform a structured IAD skin assessment according to the GLOBIAD Tool. Estimate the 
IAD affected area in cm2 using the measurement sheet provided by the sponsor (either of 
the total affected IAD area inclusive signs of erythema or with focus on skin loss only). Fill 
out the IAD study diary with regard to skin assessment information. 
5.  Photographs should be taken on Day 04, 07, 10, 13, 16, 19 and End of Study (Day 21 or 
discontinuation). Additional photos should also be taken at the first day no evidence of 
IAD is present (e.g. no erythema, no skin damage), i.e. transition from IAD1 to IAD free. If 
a patient has IAD 2 skin lesions/skin loss, additional photos should be taken on the first 
day of 100% re-epithelialization, i.e. IAD2 transition to IAD 1. Photographs must be taken 
according to the site procedure manual. Photos must be uploaded into the database if 
they refer to a study endpoint – either Day 01, Day 21, IAD2 to IAD1 or IAD1 to IAD free. 
Photos should be kept on the respective SD memory cards, labelled according to the site 
procedure manual and stored in the IAD study diary.  
6. Depending on the randomization allocation apply Cavilon Advanced Skin Protectant (Day 
04, Day 07, Day 10, Day 13, Day 16, Day 19) or the IAD hospital standard care product 
following the hospital medical routine/interval  
7. Day 04, Day 07, Day 10, Day 13, Day 16, Day 19 (+/- 1 day): 
Ask the patient to indicate the IAD pain level before, during and after the application of 
Cavilon Advanced Skin Protectant or the IAD hospital standard care product using the 
Wong-Baker FACES® Pain Rating Scale (assessment only for cognitively healthy 
patients according to the judgement of the study nurse). Document observations 
regarding weeping/exuding and bleeding after product application. 
8. Track IAD care information over the day/night and fill out the IAD study diary 
(incontinence status, use of urinary catheter, use of fecal management system, frequency 
of absorbent pad or diaper changes, frequency of intimate cleansing procedures, 
application frequency of IAD care products, IAD specialist appointments/visits) 
9. Capture detailed information with regard to the use of certain IAD care products such as 
cleansing products, skin protectants building up the moisture barrier, IAD wound 
dressings or other products if applicable [product name, treatment duration period, 
product type, manufacturer, REF number (indicates the manufacturer’s catalogue number 
so that the medical device can be identified), packaging unit, number of containments 
used for the study]  

  
 
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10. Record adverse events if applicable 
11. Record protocol deviations if applicable 
 
 
 NOTE: Any recurrence of IAD in both study groups is to be examined. If the hospital 
routinely does not use IAD prevention products, the recurrence of IAD is still to be 
observed for the group allocated to hospital IAD standard care. In this case, the study 
procedures of “Application: Comparator” and “Pain Score: Application” no longer apply 
(Appendix 24.1 B).  
 
Study Schedule: End of Study (Day 21 or discontinuation) 
1. Perform skin cleansing 
2. Ask the patient to indicate the IAD pain level before and during cleansing using the 
Wong-Baker FACES® Pain Rating Scale (assessment only for cognitively healthy 
patients according to the judgement of the study nurse).  
3. Perform a structured IAD skin assessment according to the GLOBIAD Tool. Estimate the 
IAD affected area in cm2 using the measurement sheet provided by the sponsor (either of 
the total affected IAD area inclusive signs of erythema or with focus on skin loss only). Fill 
out the IAD study diary with regard to the skin assessment information. 
4. Take photographs of the study area according to the site procedure manual. Upload the 
end of study photos into the photo database. 
5. Track IAD care information and fill out the IAD study diary (incontinence status, use of 
urinary catheter, use of fecal management system, frequency of absorbent pad or diaper 
changes, frequency of intimate cleansing procedures, IAD specialist appointments/visits). 
Collect the IAD study diary at the end of the study. 
6. Check the completeness of the information with regard to the use of certain IAD care 
products at the end of the study  
7. Record adverse events if applicable 
8. Record protocol deviations if applicable   
 
7.5 
Equipment 
 
 
The following equipment will be provided by the sponsor to the sites:  
 
Digital photography equipment 
 
IAD Measurement Sheet 

  
 
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Stopwatch 
 
Scale  
 
7.6 
Replacement of patients 
 
Patients who discontinue before the first product application will be replaced with another 
patient. 
 
8. 
Study device(s) and comparator(s) 
 
8.1 
Description of the exposure  
 
Cavilon Advanced Skin Protectant will be applied every 72 hours in this study.  
The comparator products will be applied according to the local hospital IAD care intervals 
following the hospital medical routine. 
 
8.2 
Number of study devices 
 
Cavilon Advanced Skin Protectant will be applied 7 times in maximum for a study period of 
21 days. Sufficient amounts of applicators will be shipped to the study centers.  
 
8.3 
Justification of the choice of comparator(s) 
 
The intention of the study is to assess the effects of Cavilon Advanced Skin Protectant in 
comparison to local hospital IAD standard care regime. In the comparator group the patients 
will be treated with the usual hospital IAD care products according to the medical routine of 
the hospital. 
 
8.4 
Other medical device or medication 
 
Not applicable  
 
8.5 
Regulatory requirements of study material 
 
3M™ Cavilon™ Advanced Skin Protectant is a CE-marked medical device class IIa 
according to the Medical Device Directive 93/42/EEC, Annex IX, rule 4. 
 
 

  
 
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9. 
Patients 
 
9.1 
Inclusion criteria 
 
Patients may be enrolled into this study if the answers to all these questions are yes. 
 
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 or IAD category 2A in the study area*? 
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? 
 
*NOTE: Study Area 
The study area is defined as the sacral region going down to the upper thighs, bordered 
approximately 5 cm below the gluteal fold. 
 
            
 Study Area: IAD has to be present in this zone at the start of the study  
 
9.2 
Exclusion criteria 
 
Patients are excluded from participation in this study if any of the answers to these questions 
are yes.  
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? 

  
 
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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?  
 
9.3 
Criteria and procedures for patient withdrawal or discontinuation 
 
The following withdrawal/discontinuation criteria are defined for the study: 
1. Patient develops a stage III, IV or unstageable pressure ulcer or any other deep tissue 
injury in the study area. 
2. Patient develops a fungal, bacterial or viral infection or other condition requiring the use of 
topical medication or product in the area treated with IAD products.  
3. Patient develops any condition which, in the opinion of the Investigator, requires 
discontinuation from the study including pregnancy. 
 
The date and reason for withdrawal/discontinuation will be documented in the “end of 
study” documentation and recorded as adverse event if applicable.  
 
9.4 
Point of enrolment 
 
The patient is enrolled for the study if the patient meets all inclusion and exclusion criteria 
and signed the informed consent form.  
 
9.5 
Total expected duration 
 
The total expected duration of the study is 10 months including an enrollment period of 9 
months.  
 
9.6 
Expected duration of each patient’s participation 
 
The maximum duration of each patient’s participation is 21 days. If IAD heals before 21 days 
and the patient is still incontinent, the patient will stay in the study to assess IAD recurrence 
rate with continued application of the study device (Cavilon Advanced Skin Protectant) or in 
the case the patient is allocated to the local IAD care regime with products following the local 

  
 
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IAD prevention regime.  If IAD heals before 21 days and incontinence discontinued or 
incontinence constituents are not in direct contact with the skin anymore, the patient will be 
released from the study. Patients discharged from the hospital prior to 21 days fulfill the 
requirements for study completion and are not followed-up outside of the hospital. 
The maximum patient participation is 21 days. If IAD heals before 21 days and the patient is 
still incontinent, the patient will stay in the study in order to assess the IAD recurrence rate. 
The patient will continue treatment either with Cavilon Advanced Skin Protectant or the local 
IAD care regime depending on the assigned study arm.  
If IAD heals before 21 days and the patient is no longer incontinent (or incontinence 
constituents are not in direct contact with the skin anymore) the patient will be released from 
the study irrespective of allocation group.  
Patients that have completed at least 5 days, but terminate the study prior to 21 days i.e. due 
to hospital discharge, fulfill the requirements for study completion and are not followed-up 
outside of the hospital.  
Note: Any recurrence of IAD in both study groups is to be examined. If the hospital routinely 
does not use IAD prevention products, the recurrence of IAD is still to be observed for the 
group allocated to standard care. In this case, the study procedures of “Application: 
Comparator” and “Pain Score: Application” no longer apply (Appendix 24.1 B). 
 
9.7 
Number of patients required 
 
Due to the exploratory design no formal a priori hypothesis is defined. The intention is to 
learn more about the effect size of certain variables such as healing outcome when 
compared to different local IAD care regimes in hospitals. The results of the study will be 
used to examine the feasibility of a potential subsequent confirmatory RCT. 
 
Total: n = 60 patients  
Stratum 1: n = 30 IAD 1A patients  
                        (persistent redness without clinical signs of infection)                  
Stratum 2: n = 30 IAD 2A patients  
                                            (skin loss without clinical signs of infection) 
  
 
The patients will be allocated 1:1 to either Cavilon Advanced Skin Protectant or hospital IAD
 
standard care. 
 

  
 
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Each site is expected to recruit 10 IAD 1A and 10 IAD 2A patients: 
5 IAD 1A patients allocated to Cavilon Advanced Skin Protectant 
5 IAD 1A patients allocated to hospital IAD care 
5 IAD 2A patients allocated to Cavilon Advanced Skin Protectant 
5 IAD 2A patients allocated to hospital IAD care  
 
9.8 
Enrolment period 
 
 
       The enrollment period is expected to be 9 months.  
 
 
10. Treatment of patients 
 
The patients will be treated either with Cavilon Advanced Skin Protectant (study device) or IAD 
hospital standard care (comparator) 
 
Treatment with Cavilon Advanced Skin Protectant  
Cavilon Advanced Skin Protectant will be applied to the study area that is defined as the sacral 
region going down to the upper thighs, bordered approximately 5 cm below the gluteal fold (IAD 
affected as well as unaffected skin). The genital area and the frontal skin folds will be treated only in 
case of visible IAD and only for the IAD affected skin. In consideration of the manufacturer’s 
instruction for use no topical medication or other product shall be applied on top of the barrier film 
because the effectiveness of either film or medication might be reduced. 
Application Cavilon Advanced Skin Protectant  
 Complete Area (Treatment/Prevention)    
 ONLY VISIBLE IAD (Treatment) 
 
Treatment with IAD hospital standard care products  
The hospital standard care products of the comparator group will be applied to the skin areas 
following the local hospital procedures and considering the manufacturers’ instructions for use 
especially with regard to contraindications. The use of topical medication or product other than the 
IAD treatment is not allowed for the study area in the comparator group.  
 
 
 
 

  
 
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11. Assessment of effects/performance 
 
11.1 Effect/performance parameters 
 
Cavilon Advanced Skin Protectant in comparison to IAD Hospital Standard Care 
 
IAD Healing/Improvement 
✓ IAD severity category according to the Ghent Global IAD Categorization Tool [33] 
evaluated by the research study nurses on-site 
IAD 1A: persistent redness without clinical signs of infection 
IAD 1B: persistent redness with clinical signs of infection 
IAD 2A: skin loss without clinical signs of infection 
IAD 2B: skin loss with clinical signs of infection 
IAD free: skin free of any IAD signs, including erythema  
✓ IAD affected area in cm2 evaluated by the research study nurses on-site 
Total IAD affected area inclusive signs of erythema (measurement sheet estimate) 
Area affected by IAD skin loss (measurement sheet estimate) 
✓ IAD severity category according to the GLOBIAD Tool evaluated by the blinded 
assessor based on the photographs of the study area that is defined as the sacral 
region going down to the upper thighs, bordered approximately 5 cm below the 
gluteal fold. 
IAD 1A: persistent redness without clinical signs of infection 
IAD 1B: persistent redness with clinical signs of infection 
IAD 2A: skin loss without clinical signs of infection 
IAD 2B: skin loss with clinical signs of infection 
IAD free: skin free of any IAD signs, including erythema 
✓ IAD affected area in cm2 traced by the blinded assessor based on the photographs 
of the study area. 
Total IAD affected area inclusive signs of erythema (software calculation in cm2) 
Area affected by IAD skin loss (software calculation in cm2) 
✓ Time to healing in days 
Number of days to achieve improvement in severity category according to the 
GLOBIAD Tool or days until complete healing without any signs of erythema 
 
 

  
 
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Prevention of IAD Deterioration and Recurrence   
✓ IAD severity category according to the Ghent Global IAD Categorization Tool 
evaluated by the research study nurses on-site and the blinded assessor based on 
the photographs of the study area. 
  
Pain Assessment  
(only for cognitively healthy patients according to the judgement of the study nurse  
✓ IAD pain scores according to the Wong-Baker FACES® Pain Rating Scale at the 
start and the end of the study (pain scores 0 – 10) 
✓ Pain scores according to the Wong-Baker FACES® Pain Rating Scale associated 
with the incontinence cleanup (pain scores 0 – 10) 
✓ Pain scores according to the Wong-Baker FACES® Pain Rating Scale associated 
with the IAD product application (pain scores 0 – 10)   
  
Material cost and resource use  
✓ Material cost based on the information with regard to the utilization of certain IAD 
care products such as cleansing products, skin protectants building up the moisture 
barrier, IAD wound dressings or other products, their used quantity, application 
frequency and duration of use. 
✓ Resources involved in the IAD therapy (e.g. number of nurses or specialists/ number 
of interventions) 
IAD Nursing Time 
✓ Time taken to clean up incontinence in minutes 
✓ Time taken to apply the skin protectant building up the moisture barrier and other 
products that might be needed to prepare the skin ( e.g. lotions to dry-out lesions 
before applying the skin protectant building up the moisture barrier) 
 
11.2 Assessment method 
 
Barthel Index [26] 
The Barthel Index will be completed at the start of the study to characterize the patients with 
regard to their degree of independence in activities of daily living. The evaluation addresses 
10 items: help needed with feeding, help needed with transfers e.g. from chair to bed, help 
needed with grooming, help needed with toilet use, help needed with bathing, help needed 

  
 
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with walking, help needed with climbing stairs, help needed with dressing, presence or 
absence of fecal incontinence and presence or absence of urinary incontinence. The 
possible scores range from 0 – 100, with lower score indicating increased disability.  
 
Braden Scale for Predicting Pressure Sore Risk [29, 30] 
The Braden Scale will be completed at the start of the study to assess the patient’s level of 
risk for development of pressure ulcers. The evaluation is based on six indicators: sensory 
perception, moisture, activity, mobility, nutrition, and friction or shear. Total possible scores 
range from 6-23, with lower score indicating a higher risk of developing a pressure ulcer.  
Wong-Baker FACES® Pain Rating Scale [31] 
This pain assessment tool was originally created with children for children to help them 
communicate about their pain. Faces with different expressions from smiling to crying 
facilitate the communication as anchor for pain intensity scale 0 – 10, with higher score 
indicating more pain. The nurses will ask the patients to choose the face that best depicts 
the pain they are experiencing. Only cognitively healthy patients according to the judgement 
of the study nurse will be asked. The IAD pain scores will be assessed before and during 
cleansing following the local hospital cleansing procedure. In addition the IAD pain scores 
will be measured before, during and after application of the skin protectant building up the 
moisture barrier.  
Pain assessment instructions (not valid for patients with reduced consciousness or dementia) 
1. 
Explain to the patient that each face represents a person who has no pain (hurt), or 
some, or a lot of pain 
 
 
 
 
 
 
 
 
 
Figure 1: © 1983 Wong-Baker FACES Foundation. www.WongBakerFACES.org. Used with permission 

  
 
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2. Face 0 doesn’t hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 
hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, 
although you don’t have to be crying to have this worst pain. 
3. Ask the patient to choose the face that best depicts the pain they are experiencing. 
 
 
IAD Nursing Time 
The time taken to clean up incontinence and to administer the IAD treatment products will be 
measured with a stopwatch at Day 04 (+/- 1 day) preferably in the presence of fecal 
constituents. Additionally, the skin protectant building up the moisture barrier will be weighed 
before and after application for those patients allocated to the usual IAD hospital care regime  
 
Nursing Time Instructions: 
 
Preparation:    
1. Collect supplies and prepare the room 
2. Familiarize with the sponsor provided stopwatch 
3. Remove diapers/pads. Dispose coarse dirt that can be grabbed with a wipe. 
 
 
Time to clean up incontinence (back side & front):    
1. Timekeeper starts stopwatch when nurse indicates start of cleansing procedure with 
picking up the cleanser 
2. 
Timekeeper stops stopwatch when nurse indicates cleansing procedure is complete 
(exclusive time to cleanup location) 
  
 
Time to administer IAD treatment products: 
 
                        
  Study area: Sacral region going down to the upper thighs, bordered   
 
 
 
                          approximately 5 cm below the gluteal fold.  
1. Familiarize with the sponsor provided scale  
2. Weigh the skin protectant building up the moisture barrier if the patient is allocated to 
the IAD hospital standard care group (content in gram before application) 
3. Timekeeper starts stopwatch when nurse indicates start of application of IAD 
product(s) with product in hand (IAD product(s): skin protectant building up the 
moisture barrier and other products such as dry-out lotions to prepare the skin if 
needed)   

  
 
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4. Timekeeper stops stopwatch when nurse indicates product application is finished 
5. Weigh the skin protectant building up the moisture barrier if the patient is allocated to 
the IAD hospital standard care group (content in gram after application)  
 
 
IAD Skin Assessment  
 
Ghent Global IAD Categorization Tool [33] 
The study nurses will conduct daily skin assessments to determine the IAD severity category 
according to the GLOBIAD Tool definitions (appendix 24.2):   
IAD 1A: persistent redness without clinical signs of infection 
IAD 1B: persistent redness with clinical signs of infection 
IAD 2A: skin loss without clinical signs of infection 
IAD 2B: skin loss with clinical signs of infection 
IAD free: skin free of any IAD signs, including erythema 
The IAD severity category is to be documented in the IAD study diary.  
The study nurses will receive a training regarding the GLOBIAD Tool at start of study.  
In addition, the nurses will be trained in signs of infection and how to discriminate 
Incontinence-associated dermatitis from pressure ulcers. 
Measurement Sheet to estimate the IAD affected area  
The measurement sheet provided by the sponsor will be used on a daily basis to estimate 
the total area affected by IAD inclusive signs of erythema and in addition the area that is 
affected by skin loss only (skin is moist, as the epidermal layer is missing). The predefined 
markings of the measurement sheet will help to provide a rough estimate and to determine 
the cm2 cluster range for the study documentation. All areas with IAD signs inclusive 
erythema or of skin loss will be summed up for the front and back side separately. The 
measurement sheet is to be used without contact to patient’s skin.  
 
Blinded IAD skin assessment based on photographs 
All study nurses will receive an intensive training in digital photography to ensure consistent 
picture quality throughout the study. The nurses will take the pictures according to the 
instructions of the site procedure manual. The central reader will conduct a blinded skin 
assessment according to the independent review manual and  evaluate up to four photo 
documentation time points per patient depending on his/her IAD severity category beginning 
of the study. The following photo documentation will be assessed by the central reader 

  
 
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according to the independent review manual: 
(1) Photos at the start of the study (Day 01) 
(2)  Photos to confirm the endpoint of 100% re-epithelialization of IAD 2 lesions for patients 
that started with skin loss beginning of the study (first time) 
(3) Photos to confirm the complete healing endpoint (first time; skin free of any IAD signs, 
including erythema)  
(4) Photos at the end of the study (Day 21 or discontinuation) 
The  photos for the above mentioned study relevant time points will be uploaded into a photo 
database that enables centralized independent blinded assessor review. 
All other photos taken on Day 04, 07, 10, 13, 16, 19 will be used as back-up photos for the 
study. The back-up photos are to be kept on the SD memory cards and stored in the IAD 
Study Diary. The blinded skin assessor will categorize the severity of IAD according to the 
GLOBIAD Tool. In addition, the blinded skin assessor will trace the area affected by IAD 
inclusive signs of erythema and the area affected by skin loss only. The software will 
calculate the area in cm2 based on the tracing information. At the start of the study the 
blinded skin assessor will receive a training with regard to the tracing procedure, 
photography database and software. 
 
IAD Care Assessment 
 
The study nurses together with the ward nurses will collect the information needed to 
 
calculate the material cost based on product utilization, application frequency and days of 
 
treatment in the IAD study diary. On a daily basis the nurses will track the following  
 
information for each day stayed in the hospital during the study participation (day & night): 
 
incontinence status continued/discontinued, presence of urinary catheter or fecal 
 
management system, number of absorbent pad or diaper changes, number of intimate 
 
cleansing procedures, number of applications regarding Cavilon Advanced Skin Protectant 
 
or local IAD care products and number of IAD related visits of specialists. In addition, the IAD 
 
care products will be specified in more detail in the eCRF providing information such as 
 
product name, treatment duration period, product type, manufacturer, REF number 
 
(indicates the manufacturer’s catalogue number so that the medical device can be 
 
identified),  packaging unit, number of containments used for the study. The study nurses will 
 
receive a training how to document the information at the start of the study.  
 

  
 
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12. Monitoring 
 
The present study is an international study with study sites in different European countries. Sites will 
be initiated in a site initiation visit. On-site monitoring visits will be conducted by sponsor or CRO 
authorized personnel as frequently as necessary. Monitors will record dates of the visits in a study 
site visit log that will be kept at the study site.  
During monitoring visits, monitors will compare the data entered into the eCRFs with source 
documents such as the hospital or clinic records and the IAD study diary. The nature and location of 
all source documents will be identified to ensure that all sources of original data required to complete 
the eCRF are known to the sponsor and study-site personnel and are accessible for verification by 
the sponsor study-site contact. If electronic records are maintained at the study site, the method of 
verification will be discussed with the study-site personnel.  
No audits are planned for the present study. The sponsor reserves the right to carry out audits if 
deemed necessary. Sites will be informed about the audit no less than 2 weeks prior to the audit.  
The institutions (sites), the investigators and the participating patients have to agree to give monitors, 
auditors and inspectors (authorized persons) free access to the medical records of the study 
participants. 
 
12.1 Source data 
100% source data verification will be performed for patients’ informed consent and key 
patient data. Details will be described in the Monitoring Manual. Throughout the study, sites 
will be monitored for patient enrolment. 
Key monitoring activities at sites will comprise: 
• Review and check of Investigator Site File for completeness and correctness (including 
 
positive ethics committee vote, list of EC participants, signature/delegation log, patient 
 
enrolment log, site staff qualification documentation)  
• Check of signed and dated Informed Consent Form for every patient 
• Check of eligibility of every patient 
• Source data verification as specified in the Monitoring Manual 
• Check of documentation of (S)AEs 
Investigators agree to enable direct access to source documentation (medical records, IAD 
study diary) for the purpose of verifying data recorded in the eCRF for consistency with 
original source data. Findings from monitoring reviews of eCRFs and source documents will 
be discussed with the study-site personnel. The sponsor expects that, during monitoring 
visits, the relevant study-site personnel will be available, the source documentation will be 

  
 
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accessible, and a suitable environment will be provided for review of study-related 
documents.  
 
13. Data management 
 
13.1 Data review, database cleaning, data query management 
 
Electronic Data Capture (eDC) will be used for this study. The study data will be transcribed 
by study-site personnel from the source documents into an electronic CRF, and transmitted 
in a secure manner to the sponsor/authorized CRO within the time agreed upon between the 
sponsor and the study site. The investigator’s study file contains the source data location list.   
The investigator has to ensure accuracy, completeness and timeliness of the data reported 
in the eCRFs, in all required reports and in the investigator’s study file. The investigator has 
to verify that all data entries in the eCRFs are accurate and correct.  
Reportable events will be communicated to authorities and sites according to the sponsor’s 
SOPs.  
Data will be entered into a validated electronic CRF using the authorized CRO’s certified 
electronic data capture (eDC) system. Programmed data cleaning checks will be used in 
addition to manual review to check for discrepancies and to ensure consistency of data. An 
electronic audit trail system will be maintained within the system to track all changes in the 
database once the data have been saved into the system. Regular backups of the electronic 
data will be performed. Furthermore, the CRO authorized personnel will regularly review 
eCRFs for accuracy and completeness during on-site monitoring visits and after transmission 
to the sponsor. Discrepancies will be resolved with the investigator or designee, as 
appropriate.  
All site-related eCRF entries, corrections, and alterations must be made by the investigator 
or other authorized study-site personnel. If necessary, queries will be generated in the eDC 
tool. If corrections to data are needed after the initial entry in the eCRF, this can be done in 
either of the following ways: 
• Investigator and study-site personnel can make corrections in the eDC tool at their own 
 
initiative or as a response to an auto query generated by the eDC tool. 
• Sponsor or sponsor delegate can generate queries for resolution by the investigator and 
 
site personnel. 
Any change or correction to the eCRF after first entry and saving must be accompanied by a 
reason for the change. Corrections made after the investigator’s review and signing (by 

  
 
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means of a password/electronic signature) of the completed eCRF will have to be 
reapproved by the investigator. The investigator will have to maintain a list of personnel 
authorized to enter data into the eCRF.  
 
 
13.2 Verification, validation and securing of eDC system  
 
The certified eDC system used for the study database integrates numerous functions from 
the areas of electronic data capture, double-data-entry and data management in one 
application with centralized data storage. The system complies with all relevant GCP and 
FDA regulations, in particular with 21 CFR Part 11 offering a full audit trail, user and role 
management with electronic signatures. Data storage is secure and data are accessible to 
authorized personnel, only. 
 
 
 
13.3 Data retention and archiving 
 
In compliance with ICH/GCP guidelines, the investigator/ institution will maintain all eCRFs 
and all source documents that support the data collected from each patient, as well as all 
study documents, Essential Documents for the Conduct of a Clinical Trial, and all study 
documents as specified by the applicable regulatory requirement(s). The 
investigator/institution will take measures to prevent accidental or premature destruction of 
these documents. 
Study documents and materials have to be archived at investigator sites and at the 
sponsor’s archive for no less than 10 years. Documents will be retained for a longer period if 
required by the applicable country regulatory requirements. 
If the responsible investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the investigator relocate or dispose of any 
study documents before having obtained written approval from the sponsor. 
If it becomes necessary for the sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the investigator/institution must permit access to such 
reports. 
  

  
 
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The sponsor will archive study documents and study data electronically and as paper 
versions.  
 
13.4 Notification requirements and time frames 
 
The study may be subject to auditing activities by appropriate regulatory authorities. It is 
important that the Investigator and relevant study personnel are available during 
audits/inspections and that sufficient time is devoted to the process. Data requested by 
regulatory authorities have to be provided within the required time frames. 
 
13.5 Corrective and preventive actions and principal investigator disqualification criteria 
 
The Investigator and respective study personnel will be trained by the sponsor and/or 3M 
authorized representatives on study documentation to ensure the accuracy and 
completeness of the data reported in the eCRFs and other documents such as study diaries. 
The site monitor will verify that study records are adequately maintained and address 
necessary corrective actions if needed. Submission of knowingly false information from the 
Investigator to 3M or failure to comply with the study protocol and applicable regulations will 
disqualify the Investigator from the study. 
 
13.6 Other aspects of clinical quality assurance 
 
 
3M and authorized CRO are responsible for implementing and maintaining quality assurance 
and quality control systems through written standard operating procedures to ensure that 
this study is conducted and data are generated, documented and reported, in compliance 
with the protocol, GCP and regulations. Study monitoring is carried out to accomplish this.  
 
14. Deviations from clinical investigation plan 
 
14.1 Amendments 
 
The party initiating an amendment must confirm it clearly in writing using the 
Amendment/Administrative Revision Form of the ethics committee if applicable. It must be 
signed and dated by 3M and, in the case of a significant amendment, the Investigator.  
A significant amendment means one that affects the safety, rights or welfare of patients, the 
scope of the study or scientific quality. 

  
 
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3M will submit significant protocol amendments to the Investigator for submission to the 
ethics committee. 3M will also notify the Investigator when a protocol amendment may be 
implemented. 
  
14.2 Protocol Deviations 
 
A protocol deviation is a departure from the protocol that will likely affect the safety, rights or 
welfare of patients, the scope of the clinical study or the scientific quality. 
A protocol deviation is only for an individual patient. Each protocol deviation will be 
documented by completing a Protocol Deviation Case Report Form. This documentation will 
include the type of deviation and a description of the circumstances surrounding the 
deviation.   
 
15. Device accountability 
 
 
3M requires investigators to maintain accountability and adequate inventory security of the study 
 
device at all times. The investigator or designee will: 
• Upon receipt of study device, check the contents and return the completed confirmation of 
 
receipt to the sponsor. 
• Keep study device in a secure storage area, accessible only to authorized individuals. 
• Dispense study device only to patients properly enrolled into the study. 
• Return all unused study device to 3M at the end of the study, or dispose of as agreed upon. 
 
16. Statement of compliance 
 
 
This study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki. All regional or national regulations will be followed, as appropriate. The study 
will not begin until the local Ethics Committees approved the study. Any additional requirements 
imposed by the Ethics Committees will be followed, if appropriate. The CE-marked study device will 
be used within its intended use. 3M recognizes its liability in law to compensate for any injuries 
sustained by patient participation in this study in accordance with the relevant guidelines of the 
countries where the study is conducted. 
 
 

  
 
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17. Informed consent process 
 
The Investigator must ensure that written informed consent is obtained from the patient or patient’s 
legally authorized representative before including any patient, and before conducting any study-
related assessments. Informed consent may be given by the legally authorized representative only if 
a patient is unable to make the decision to participate in the study (e.g. seriously ill or unconscious 
patient, mentally ill person, mentally handicapped person). In such cases, the patient shall also be 
informed about the clinical study within his/her ability to understand. The Investigator must provide 
the prospective patient or the prospective patient’s legally authorized representative, with sufficient 
opportunity to consider whether or not to participate, and minimize the possibility of coercion or 
undue influence. The process is designed to 1) give the patient and/or legally authorized 
representative all the information that he/she needs, 2) ensure that the patient and/or legally 
authorized representative understands the information and 3) give the patient and/or legally 
authorized representative a chance to consider study participation. The process should permit the 
patient and/or patient’s legally authorized representative to ask questions and exchange information 
freely. Specifically, the Investigator is to explain to each patient and/or patient’s legally authorized 
representative all elements of informed consent. After the explanation, the patient or legally 
authorized representative will voluntarily sign and date the consent/assent form if they wish to 
participate in the study. A copy of the consent/assent form must be provided to the patient or the 
patient’s legally authorized representative. A signed and dated copy of the consent/assent form must 
be maintained in the Investigator Site File at all times. The informed consent process must be 
followed, and the patient’s participation in the study, must be documented in the patient’s medical 
record/chart. 
 
17.1 Special circumstances for informed consent 
17.1.1 Patient needing legally authorized representatives 
 
Informed consent process is to be followed as described under 17. 
17.1.2 Patient unable to read or write 
 
If patient is unable to read or write an independent witness must be present throughout 
the process. The written informed consent form and any other information must be read 
aloud and explained to the prospective study participant or his/her legally authorized 
representative and, whenever possible, either must sign and personally dated the 

  
 
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informed consent form. The witness also signs and personally dates the informed 
consent form attesting that the information is accurately explained and that informed 
consent is freely given. 
 
18. Adverse events, adverse device effects and device deficiencies 
 
18.1 Assessment of safety 
 
The study assesses the effects of a CE-marked device used within its intended use in 
comparison to hospital IAD standard care. Following the guidance of MEDDEV 2.12 rev 8 
“Guidelines on a medical devices vigilance system” all incidents will be assessed and 
reported according to the reporting modalities of the national competent authorities. The 
national regulations and local requirements for clinical studies with CE-marked device will 
determine which safety issues are to be reported to the ethics committees/institutional review 
boards. Beside the regulatory framework, the sponsor defines the following safety 
documentation for this study: The principal measure of safety will be the occurrence and 
nature of serious adverse events probably or possibly related to the study device (i.e. serious 
adverse device effects) or hospital IAD care products used in this study. Additionally, all 
adverse events probably or possibly related to the study device (i.e. adverse device effects), 
the hospital IAD care products or the study procedures will be documented. Adverse events 
with direct effect on the skin assessment area are of interest and will be documented as well. 
Deficiencies of the study device with respect to its identity, quality, durability, reliability, safety 
or performance including malfunctions, use errors, and inadequate labelling are to be 
documented on a sponsor provided device deficiency form but not in the eCRF (meaning 
quality complaints and near incidents of the study device). This includes any discovery or 
malfunction or deterioration in the characteristics and/or performance of the study device, as 
well as any inadequacy in the labelling or in the instructions for use which might have led to 
a deterioration in the state of health of patient or user if the circumstances would have been 
less fortunate or the event would not have been prevented due to the timely intervention of 
health care personnel (all device deficiencies that led to any hazard for the patient have to 
be regarded as adverse device effect and are to be documented in the eCRF). 
 
NOTE: Untoward medical occurrence, unintended disease or injury or any untoward clinical 
signs (including an abnormal laboratory finding) in patients, users or other persons that are 
not linked to the products or procedures used in this study or do not directly affect the skin 

  
 
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assessment area are to be excluded from documentation including all internal diseases 
unless local regulations provide for this. 
 
18.1.1 Safety parameters 
 
The main safety parameters of this post-market IAD care study are the number and 
nature of serious adverse events possibly or probably related to the study device (i.e. 
serious adverse device effects) or to the IAD care products used in the comparative 
group.  
Additionally, the number and nature of the following adverse events will be documented: 
- adverse events probably or possibly related to the study device (i.e. adverse device 
effects) 
- adverse events probably or possibly related to one of the IAD hospital care products  
- adverse events probably or possibly related to one of the study procedures 
- adverse events with direct effect on the skin assessment area. Examples are pressure 
ulcers or skin infections such as fungal/bacterial/viral infections within the skin area 
observed for this study. 
All national and local requirements with regard to safety documentation will be considered 
for this study. Adverse events not mentioned in the list above will not be 
collected/analyzed during this study.  
 
 
18.1.2 Assessment of methods 
 
 
Safety parameters defined for this study will be collected for all study participants 
beginning at Day 01 until the final study visit, or until the patient is discharged from the 
hospital. The Adverse Event Case Report Form will be used to capture any safety-related 
concerns (eCRF). Device deficiencies regarding Cavilon Advanced Skin Protectant will be 
documented on the Device Deficiency Form (i.e. quality complaints and near incidents). 
The Device Deficiency Form is stored in the Investigator Site File. All device deficiencies 
that led to any hazard for the patient have to be regarded as adverse device effect and 
are to be documented in the eCRF/Adverse Event Case Report Form. 
 
 
 

  
 
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18.2 Foreseeable adverse events and anticipated adverse device effects 
 
An allergic reaction to any of the ingredients of Cavilon Advanced Skin Protectant would 
constitute an anticipated adverse event according to the manufacturer’s instructions for use.  
 
18.3 Definitions 
 
The definitions given in this section are the official definitions of the ISO 14155:2011 “Clinical 
investigation of medical devices for human subjects – good clinical practice”. The standard 
addresses good clinical practice for clinical investigation to assess the safety or performance 
of non-CE marked devices but the principles set forth in this standard also apply to all other 
clinical investigations and should be followed as far as possible, considering the nature of 
the clinical study and the requirements of national regulations. 
 
Adverse Device Effect  
 
Adverse event related to the use of an investigational medical device. 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
 
Adverse Event 
  
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, whether or 
not related to the investigational medical device. 
NOTE 1: This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
 
 
 

  
 
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Device Deficiency  
 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance 
NOTE: Device deficiencies include malfunctions, use errors, and inadequate labelling. 
 
Serious Adverse Event  
 
Adverse event that: 
a) led to death, 
b) led to serious deterioration in the health of the subject that either:  
1) resulted in a life-threatening illness or injury, or 
2) resulted in a permanent impairment of a body structure or a body function, or  
3) required in-patient or prolongation of existing hospitalization, or 
4) resulted in medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
c) led to fetal distress, foetal death or a congenital abnormality or birth defect. 
 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the 
Clinical Investigation Plan, without a serious deterioration in health, is not considered a 
serious adverse event. 
NOTE: This includes device deficiencies that might have led to a serious adverse event if a) 
suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate. These are handled under the SAE reporting system. 
 
Serious Adverse Device Effect  
 
Adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event. 
 
 
 
 
 
 
 

  
 
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18.4 Reporting and timelines 
 
18.4.1 Reportable events 
 
Incidents will be reported to the national competent authorities. According to MEDDEV 
2.12. rev 8 an incident is defined as any malfunction or deterioration in the characteristics 
and/or performance of a device, as well as any inadequacy in the labeling or the 
instructions for use which, directly or indirectly, might lead to or might have led to the 
death of a patient, or user or of other persons or to a serious deterioration in their state of 
health.  
According to MEDDEV 2.12 rev 8 a serious deterioration in state of health can include 
(non exhaustive list): 
a) life-threatening illness 
b) permanent impairment of a body function or permanent damage to a body structure, 
c) a condition necessitating medical or surgical intervention to prevent a) or b). 
Examples:  
- clinically relevant increase in the duration of a surgical procedure, 
- a condition that requires hospitalization or significant prolongation of existing 
hospitalization. 
d) any indirect harm as a consequence of an incorrect diagnostic or IVD test result or as a 
consequence of the use of an IVF/ART device when used within manufacturer’s 
instructions for use 
e) fetal distress, fetal death or any congenital abnormality or birth defect  
  
The national regulations and local requirements for clinical studies with CE-marked 
device will determine which safety events are to be reported to the ethics 
committees/institutional review boards. 
 
18.4.2 Report by whom 
 
Incidents related to the study device will be reported by the 3M safety officer to the 
applicable national competent authorities. Incidents in relation to one of the hospital IAD 
care products are to be reported by the hospital to the respective manufacturer and to the 
national competent authorities.  
National regulations and local requirements of the ethics committees/institutional review 

  
 
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boards will define which events are to be reported by whom. 
 
18.4.3 Report to whom 
 
Incidents will be reported to the applicable national competent authorities. National 
regulations and local requirements of ethics committees/institutional review boards will 
define which events are to be reported. 
 
18.4.4 Report by the investigator to the sponsor 
 
The investigator shall report immediately (max. 24 hours) to the sponsor all serious 
adverse events that are probably or possibly related to one of the products or procedures 
of the study. In addition, the investigator shall report all device deficiencies that could 
have been resulted in a serious deterioration in the health of the patient or user if the 
circumstances would have been less fortunate or were not prevented due to the timely 
intervention of health care personnel (near incident). Furthermore, all emergency 
deviations from the protocol are to be reported to the sponsor within 24 hours and have to 
be documented in the Protocol Deviation Form of the eCRF. The sponsor’s Medical 
Monitor is to be informed immediately by phone and Email about the occurrence of any of 
the events described above. For all related serious adverse events (i.e., serious adverse 
device effects) the Adverse Event Form of the eCRF has to be filled out as soon as 
possible since an alert email is sent automatically by the EDC system to the sponsor’s 
Medical Monitor. Device deficiencies that could have been resulted in a serious event are 
to be documented on the device deficiency form and forwarded to the sponsor’s Medical 
Monitor as an attachment. The 3M Monitor should be cc’d to secure the communication 
flow in case the 3M Medical Monitor is not immediately available for any reason. 
 
18.4.5 Reporting form 
 
Reportable events must be reported using the official forms featured by the national 
competent authorities and ethics committees/institutional review boards on their websites 
if applicable.  
 

  
 
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18.5 Emergency contact details 
 
3M Medical Monitor:  
Dr. med. Jens Bichel 
Tel: +49 2131 144674 
Mobile: +49 160 5301044 
To: jbichel@mmm.com [cc: adreuw@mmm.com] 
 
18.6 Drug Monitoring Committee 
 
Not applicable for this study  
 
 
19. Suspension or premature termination of the clinical investigation 
 
Conditions that may warrant termination of the study by 3M include, but are not limited to the 
following: 
• 
The discovery of an unexpected, serious, or unreasonable risk to study participants 
• 
Failure of the Investigator to comply with regulations 
• 
Insufficient adherence to protocol requirements 
• 
Failure of the Investigator to enroll patients into the study at an acceptable rate 
• 
Submission of knowingly false information from the Investigator to 3M 
• 
Withdrawal of EC approval 
• 
A decision on the part of 3M to suspend or discontinue evaluation of the study device 
 
20. Publication policy 
 
In accordance with 3M’s corporate policy, the company requires disclosure of its involvement as a 
sponsor or financial supporter in any publication or presentation relating to a 3M study or its results. 
 
 
21. Data handling and record keeping 
 
21.1 
Site personal 
 
 
Prior to study initiation, the Investigator must provide 3M with a signed Investigator 
Agreement. The Agreement contains pertinent Investigator information (e.g. qualifications, 

  
 
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experience, etc.) as well as the Investigator’s commitment to conduct the study according to 
the protocol and all applicable regulations. 
 
21.2 Pre-clinical investigation documentation requirements 
 
Prior to study initiation, the Investigator must provide 3M with the following documents: 
a) Signed protocol including any amendments in place prior to study initiation 
b) Curriculum vitae for the Investigator and any Co-Investigators 
c) Ethics committee approved informed consent form 
d) Ethics committee study approval letter 
e) Ethics committee name, location and chairperson 
g) Signed Investigator Agreement with regard to the clinical study 
 
21.3 
Completion and return of case report forms 
 
 
Once the electronic forms are completed by the Investigator or study nurse, the monitor will 
review the information to ensure completeness and consistency and to ensure adequate 
quality control and assurance of patient data. Any discrepancies found during CRF review 
are to be clarified by the Investigator or study nurse. After the study the investigator will 
receive an USB stick or CD with all CRFs in PDF format extracted from the electronic Data 
Capture System.  
 
22. Final report 
 
3M will prepare a Sponsor Final Report and submit the document to all reviewing Ethics Committees, if 
required.  
 
 
 
 
 
 
 
 
 
 

  
 
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23. Bibliography 
 
1. Beeckman D et al. Proceedings of the Global IAD Expert Panel. Incontinence-associated 
dermatitis: moving prevention forward. Wounds International 2015. Available to download from 
www.woundsinternational.com 
2. Mugita Y, Minematsu T, Huang L, Nakagami G, Kishi C, Ichikawa Y, Nagase T, Oe M, Noguchi 
H, Mori T, Abe M, Sugama J, Sanada H. Histopathology of Incontinence-Associated Skin 
Lesions: Inner Tissue Damage Due to Invasion of Proteolytic Enzymes and Bacteria in Macerated 
Rat Skin. PLoS One. 2015 Sep 25;10 (9). 
3. Bliss DZ, Savik K, Harms S, Fan Q, Wyman JF. Prevalence and correlates of perineal dermatitis 
in nursing home residents. Nurs Res. 2006 Jul-Aug; 55(4): 243-251. 
4. Peterson KJ, Bliss DZ, Nelson C, Savik K. Practices of nurses and nursing assistants in 
preventing incontinence associated dermatitis in acutely/critically ill patients. Am J Crit Care 2006, 
15(3):325. 
5. Junkin J, Selekof JL. Prevalence of incontinence and associated skin injury in the acute care 
inpatient. J Wound Ostomy Continence Nurs. 2007 May-Jun; 34 (3): 260 – 269. 
6. Gray M, Beeckman D, Bliss DZ, Fader M, Logan S, Junkin J, Selekof J, Doughty D, Kurz P. 
Incontinence-associated dermatitis: a comprehensive review and update. J Wound Ostomy 
Continence Nurs. 2012 Jan-Feb; 39(1): 61-74. 
7. Campbell JL, Coyer FM, Osborne SR. Incontinence-associated dermatitis: a cross-sectional 
prevalence study in the Australian acute care hospital setting. Int Wound J 2014 Jun; 13(3): 403-
411. 
8. Borcher K, Bliss DZ, Savik K, Radosevich DM. The incontinence-associated dermatitis and its 
severity instrument: development and validation. J Wound Ostomy Continence Nurs. 2010 Sep-
Oct; 37 (5): 527-535.  
9. Bliss DZ, Zehrer C, Savik K, Smith G, and Hedblom E: An economic evaluation of four skin 
damage prevention regimens in nursing home residents with incontinence: economics of skin 
damage prevention. J Wound Ostomy Continence Nurs. 2007 Mar-Apr; 34 (2): 143-152.  
10. Long MA, Reed LA, Dunning K, Ying J. Incontinence-associated dermatitis in a long-term acute 
care facility. J Wound Ostomy Continence Nurs. 2012 May-Jun; 39(3): 318-327.  
11. Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S. A systematic review and meta-
analysis of incontinence-associated dermatitis, incontinence, and moisture as risk factors for 
pressure ulcer development. Res Nurs Health 2014 Jun; 37: 204-218.  
12. Langemo D, Hanson D, Hunter S, Thompson P, OH IE. Incontinence and incontinence-
associated dermatitis. Adv Skin Wound Care 2011 Mar; 24(3): 126-140.  

  
 
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13. Demarre L, Verhaeghe S, Van Hecke A, Clays E, Grypdonck M, Beeckman D. Factors predicting 
the development of pressure ulcers in an at-risk population who receive standardized preventive 
care: secondary analyses of a multicentre randomized controlled trial. J Adv Nurs 2015; Feb 
71(2): 391- 403.  
14. Doughty D, Junkin J, Kurz P, Selekof J, Gray M, Fader M, Bliss DZ, Beeckman D, Logan S. 
Incontinence-associated dermatitis: consensus statements, evidence-based guidelines for 
prevention and treatment, and current challenges. J Wound Ostomy Continence Nurs. 2012; 39: 
303-315.  
15. Beeckman D, Schoonhoven L, Verhaeghe S, Heyneman A, and Defloor T. Prevention and 
treatment of incontinence-associated dermatitis: literature review. J Adv Nurs. 2009 Jun; 65: 
1141-1154.  
16. Gray M, Bliss DZ, Doughty DB, Ermer-Seltun J, Kennedy-Evans KL, Palmer MH. Incontinence 
associated dermatitis: a consensus: J Wound Ostomy Continence Nurs. 2007 Jan-Feb; 34(1): 45-
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17. Shigeta Y, Nakagami G, Sanada H, Oba M, Fujikawa J, Konya C, Sugama J. Exploring the 
relationship between skin property and absorbent pad environment. J Clin Nurs. 2009; 18 (11): 
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19. Bliss DZ, Zehrer C, Savik K, Thayer D, Smith G. Incontinence-associated skin damage in nursing 
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20. Kottner J, Blume-Peytavi U, Lohrmann C, Halfens R. Associations between individual 
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23. Beitz JM. Fecal incontinence in acutely and critically ill patients: options in management. Ostomy 
Wound Manage. 2006 Dec; 52(12): 56-66.   

  
 
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24. Beeckman D. A decade of research on Incontinence-Associated Dermatitis (IAD): Evidence, 
knowledge gaps and next steps. J Tissue Viability 2016 Feb 21. Epub ahead of print. 
25. Been RA, Bernatchez SF, Conrad-Vlasak DM, Asmus RA, Ekholm B, Parks PJ. In vivo methods 
to evaluate a new skin protectant for loss of skin integrity. Wound Repair Regen. 2016 Sep; 
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management of incontinence-associated dermatitis: an open-label, nonrandomized, prospective 
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Voegeli D, Verhaeghe S, Van Hecke A, Kottner J. Development and Clinical Validation of the 
Ghent Global IAD Categorisation tool (GLOBIAD). In progress. 
 
 
24. Appendix 
 
NOTE: After IAD healing, the recurrence of IAD in both study groups is to be examined. If the hospital 
routinely does not use IAD prevention products, the recurrence of IAD is still to be observed for the group 
allocated to hospital IAD standard care. In this case, the study procedures of “Application: Comparator” 
and “Pain Score: Application” no longer apply (Appendix 24.1 B).  
 
 

  
 
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24.1 Clinical investigational schedule 
A) Patients allocated to Cavilon Advanced Skin Protectant 
Assessment 
IC 
D01 
D02 
D03 
D04 
D05 
D06 
D07 
D08 
D09 
D10 
D11 
D12 
D13 
D14 
D15 
D16 
D17 
D18 
D19 
D20 
End of Study 
(D21 or 
discontinuation)   
Informed Consent (IC) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IAD History  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medications  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Barthel Index 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Braden Scale 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Skin Cleansing 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pain Score: Cleansing 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
X 
IAD Nursing Time  
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Skin Assessment (Diary) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Photography 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
X 
Application: Study Device    
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Pain Score: Application  
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Tracking IAD Care (Diary) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IAD Product Specification  
 
X 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Adverse Events 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Protocol Deviation  
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
End of Study Form  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
         (x) = if applicable

  
 
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B) Patients allocated to hospital IAD standard care 
  
Assessment 
IC  
D01 
D02 
D03 
D04 
D05 
D06 
D07 
D08 
D09 
D10 
D11 
D12 
D13 
D14 
D15 
D16 
D17 
D18 
D19 
D20 
End of Study 
(D21 or 
discontinuation)   
Informed Consent (IC)  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IAD History  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medications  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Barthel Index 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Braden Scale 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Skin Cleansing 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pain Score: Cleansing 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
X 
IAD Nursing Time  
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Skin Assessment (Diary) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Photography 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
X 
Application: Comparator * 
 
X 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
 
Pain Score: Application  
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Tracking IAD Care (Diary) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IAD Product Specification  
 
X 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Adverse Events 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Protocol Deviation  
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
End of Study Form  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
* Hospital IAD standard care: skin protectant building up the moisture barrier or IAD wound dressing. The application frequency varies depending on the product. 
   (x) = if applicable

  
 
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24.2 Ghent Global IAD Categorization Tool  
 
IAD 1A and IAD 2A  
 
 
 
 
 

  
 
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IAD 1B and IAD 2B