Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral Skin After Loading
Phase: NA
Conditions: Pressure Ulcers
Sponsor: Charite University, Berlin, Germany

 
 
 
K l i n i k  f ü r  D e r m a t o l o g i e ,  V e n e r o l o g i e  u n d  A l l e r g o l o g i e  
K l i n i k l e i t u n g :  P r o f .  D r .  me d .  D r .  h . c .  T .  Z u b e r b i e r  ( g e s c h ä f t s f .  D i r e k t o r )  
 P r o f .  D r .  me d .  E .  S t o c k f l e t h  ( s t e l l v .  g e s c h ä f t s f .  D i r e k t o r ) ,  P r o f .  D r .  me d .  U .  B l u me - P e y t a v i  ( l t d .  O Ä )  
P r o f .  D r .  me d .  M.  Ma u r e r  ( F o r s c h u n g s d i r e k t o r ) ,  P r o f .  D r .  me d .  W .  S t e r r y  ( F o r s c h u n g ) ,  P r o f .  D r .  me d .  M .  W o r m ( L e h r e )  
 
C H A R I T É  -  U N I V E R S I T Ä T S M E D I Z I N  B E R L I N  
Gliedkörperschaft der Freien Universität Berlin und der Humboldt-Universität zu Berlin 
Charitéplatz 1  10117 Berlin  Telefon +49 30 450-50  www.charite.de 
 
Charité  Campus Mitte  10098 Berlin 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
Study Protocol 
Comparing the effects of three different support surfaces on the 
properties of heel and sacral skin after loading 
Code: CRC-PU-A-23 
Version 2.0, January 06, 2017 
 
SPONSOR 
Clinical Research Center for Hair and Skin Science, 
Department of Dermatology and Allergy,  
Charité – Universitätsmedizin Berlin  
Charitéplatz 1, 10117 Berlin, Germany  
 
 
 
PROTOCOL DEVELOPMENT 
Andrea Lichterfeld 
Anja Klasen 
Jan Kottner 
Clinical Research Center for Hair and Skin Science, 
Department of Dermatology and Allergy,  
Charité – Universitätsmedizin Berlin 
Charitéplatz 1, 10117 Berlin, Germany 
Email: jan.kottner@charite.de 
INVESTIGATOR 
Dr. Jan Kottner  
Clinical Research Center for Hair and Skin Science, 
Department of Dermatology and Allergy,  
Charité – Universitätsmedizin Berlin  
Charitéplatz 1, 10117 Berlin, Germany  
Email: jan.kottner@charite.de 
KLINIK FÜR DERMATOLOGIE, 
VENEROLOGIE UND ALLERGOLOGIE 
 
 
 
 
 
Klinik mit zertifiziertem 
Qualitätsmanagementsystem nach 
DIN EN ISO 9001:2008 
 
 
Prof. Dr. med. U. Blume-Peytavi 
ulrike.blume-peytavi@charite.de 
 
 
 
Kompetenzzentrum für Haare und Haarerkrankungen  
Tel. +49 30 450 518 257 (Diagnostik) 
Tel. +49 30 450 518 242 (Terminvereinbarung)  
Fax +49 30 450 518 952 
crc-haare@charite.de; www.hairberlin.com 
 
 
Kinderdermatologische Hochschulambulanz 
Tel. +49 30 450 618 407  Fax +49 30 450 518 952 
crc-kinder@charite.de; www.kinderdermaberlin.com 
 
 
Klinisches Studienzentrum für Haut- und Haarforschung 
Tel. +49 30 450 518 178  Fax +49 30 450 518 955 
crc-studien@charite.de; www.crcberlin.com 
www.derma.charite.de 
 

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Study code CRC-PU-A-23 
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Table of contents 
1 
Administrative Information .............................................................................................. 4 
1.1 
Title ......................................................................................................................... 4 
1.2 
Protocol version ...................................................................................................... 4 
1.3 
Funding ................................................................................................................... 4 
1.4 
Roles and responsibilities ........................................................................................ 4 
2 
Introduction .................................................................................................................... 6 
2.1 
Background and Rationale ...................................................................................... 6 
2.2 
Objectives ............................................................................................................... 7 
2.3 
Trial design ............................................................................................................. 7 
3 
Methods: Participants, interventions, and outcomes ....................................................... 8 
3.1 
Eligibility criteria ...................................................................................................... 8 
3.2 
Interventions............................................................................................................ 8 
3.3 
Outcomes and variables .........................................................................................10 
3.4 
Participant timeline .................................................................................................13 
3.5 
Sample size............................................................................................................14 
3.6 
Recruitment ............................................................................................................14 
4 
Methods: assignment of interventions ...........................................................................15 
4.1 
Assignment of interventions ...................................................................................15 
4.2 
Allocation concealment ..........................................................................................15 
4.3 
Allocation implementation.......................................................................................15 
4.4 
Blinding ..................................................................................................................15 
5 
Methods: data collection, management, analysis...........................................................16 
5.1 
Data collection and management ...........................................................................16 
5.2 
Statistical methods .................................................................................................16 
6 
Methods: monitoring ......................................................................................................17 
6.1 
Data monitoring ......................................................................................................17 
6.2 
Harms ....................................................................................................................17 
7 
Ethics and dissemination ...............................................................................................19 
7.1 
Research ethics approval .......................................................................................19 
7.2 
Protocol amendments ............................................................................................19 
7.3 
Consent ..................................................................................................................19 
7.4 
Confidentiality .........................................................................................................19 
7.5 
Declaration of interests ...........................................................................................20 
7.6 
Access to data ........................................................................................................20 
7.7 
Dissemination policy ...............................................................................................20 
8 
References ....................................................................................................................21 
 
 

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Abbreviations 
ADE 
 
 
Adverse Device Effect 
AE  
 
 
Adverse Event 
BfArM  
 
Bundesinstitut für Arzneimittel und Medizinprodukte 
CRC  
 
Clinical Research Center for Hair and Skin Science 
CRF 
 
 
Case report form 
DD 
Device deficiency 
EPUAP  
 
European Pressure Ulcer Advisory Panel 
ICF 
 
 
Informed consent form 
IIS 
 
 
Investigator initiated study 
NPUAP 
 
National Pressure Ulcer Advisory Panel 
PI 
 
 
Principal Investigator 
PPPIA  
 
Pan Pacific Pressure Injury Alliance 
PU 
 
 
Pressure ulcer 
SADE  
 
Serious Adverse Device Effect 
SAE 
 
 
Serious Adverse Event 
SCH 
 
 
Stratum corneum hydration 
SD 
 
 
Source data  
SOP 
 
 
Standard operating procedure 
TEWL  
 
Transepidermal waterloss 
 
 

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1 
Administrative Information 
 
1.1 
Title 
Comparing the effects of three different support surfaces on the skin function of heel and 
sacral skin after loading 
 
1.2 
Protocol version 
Version 1, September 25, 2015 
 
1.3 
Funding 
This investigator initiated study (IIS) is conducted by the Clinical Research Center for Hair 
and Skin Science, Department of Dermatology and Allergy, Charité – Universitätsmedizin 
Berlin. The trial is supported by Stryker®. Stryker® provides the three support surfaces 
(IsoAir, IsoGel and basic foam mattress). 
 
1.4 
Roles and responsibilities 
Project leader and scientific contact  
Dr. Jan Kottner  
Clinical Research Center for Hair and Skin Science  
Department of Dermatology and Allergy 
Charité – Universitätsmedizin Berlin  
Charitéplatz 1, 10117 Berlin, Germany  
Phone: +49 30 450 518 218  
Fax: +49 30 450 518 998  
Email: jan.kottner@charite.de 
 
Manufacturer of the study products 
Stryker Medical 
3800 E. Centre Avenue 
Portage, MI 49002 USA  
  
Protocol development 
Dr. Jan Kottner 
Anja Klasen 
Andrea Lichterfeld 
Prof. Dr. Ulrike Blume-Peytavi 

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Trial statistician  
Andrea Stroux  
Department of Biometry and Clinical Epidemiology  
Charité – Universitätsmedizin Berlin  
Charitéplatz 1, 10117 Berlin, Germany  
Phone: +49 30 8445 32 62 / 450 562 155  
Fax: +49 30 8445 4471  
Email: andrea.stroux@charite.de 
 
 
 
 
 
 
 
 
 
 
 

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2 
Introduction  
 
2.1 
Background and Rationale 
Pressure ulcers (PUs) are localized injuries of the skin and/or underlying soft tissues due to 
prolonged deformation (NPUAP, EPUAP, PPPIA 2014). In adults in supine position the 
lateral areas of the heel and the sacral area are most often affected (PU predilection sites). 
PUs are severe injuries and wounds causing a substantial burden on patients, caregivers, 
and on healthcare systems worldwide. There is common agreement, that effective PU 
prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. 
Besides risk assessment and repositioning the use of special PU preventive support surfaces 
are the key interventions in PU prevention. Support surfaces may be broadly classified into 
active (e.g. alternating mattresses) and reactive (e.g. special foams). These support surface 
allow a more even “pressure distribution” leading to lesser deformation of the skin and soft 
tissues and/or to alternating loading and off-loading to limit the time of localized compression. 
In recent years the concept of “microclimate” received increasing attention. It is defined 
as the temperature, humidity, and air-flow on and near to the skin surface. The parameters of 
skin temperature and humidity are closely related to functional and mechanical skin 
properties and to the susceptibility to PU development (Gefen 2011, NPUAP, EPUAP, PPPIA 
2014). Therefore, many support surfaces try to influence the microclimate as well. A major 
methodological challenge in current PU research is the lack of outcomes to measure the 
effects of preventive approaches. PU incidence is clearly the clinical most relevant 
parameter. However, using this dichotomous outcome well conducted RCTs require 
hundreds of patients, long recruitment and follow-up periods, and are expensive. In addition, 
there is a debate whether the current definition of PU incidence in clinical trials is really the 
best choice (Kottner, Gefen 2012). Widely agreed upon Core Outcomes Sets (Clarke, 
Williamson 2015) have not been developed in PU research so far (Nixon 2015). Attempts 
have been made, to identify possible other parameters serving as predictors or biomarkers 
for PU risk and/or early tissue damage, e.g. skin temperature, shear wave velocity based on 
ultrasound elastography, epidermal cytokines, or serum myoglobin. It is well known, that skin 
function for instance in terms of transepidermal waterloss (TEWL) is very sensitive marker of 
skin barrier changes. TEWL increases are usually associated with skin barrier impairments 
whereas TEWL decreases are associated with an intact or improved skin barrier (Rogiers et 
al. 2001). Using a standard hospital mattress, it was shown recently that this parameter 
shows a loading time depend increases in the lateral heel areas indicating subclinical skin 
damage (Kottner et al. 2015). Skin temperature and erythema increased as well; both being 
directly related to the risk of tissue damage. These functional parameters were also partly 

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Study code CRC-PU-A-23 
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related to changes in skin surface topography and elasticity (Dobos et al. 2015). Taken 
together, these results indicate that the prolonged loading causes changes in skin structure 
and function. PU preventive support surface modify the degree of skin and tissue 
deformation and/or skin temperature and moisture. Therefore, an association between the 
type and working mechanism of a PU support surface and skin function after loading is highly 
likely. Furthermore, such a relationship may be used to characterize and/or to quantify the 
performance PU support surfaces in terms of skin protection. 
 
2.2 
Objectives  
The overall aim of this explorative study is to measure skin responses of the two most 
common PU predilection sites (heel, sacral skin) after two hours loading on three different 
support surfaces and the sternal skin (control area). The following objectives are determined: 
(1) To measure the changes of skin temperature, erythema, stratum corneum hydration, 
TEWL, skin roughness and elasticity before loading (baseline) and after two hours loading at 
the right heel and sacral on three different support surfaces and the sternal skin area. 
(2) To quantify possible differences in skin response between the support surfaces. 
 
2.3 
Trial design 
This exploratory study is a randomized and controlled trial, with a cross-over design (every 
subject will lie on every support surface).   
 

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3 
Methods: Participants, interventions, and outcomes  
 
3.1 
Eligibility criteria 
Inclusion criteria 
- Healthy, female volunteers  
- 60 to 80 years 
- Body Mass Index between 18.5 and 29.9 kg/m2  
- Non-Smoker of at least one year 
- Absence of skin diseases or scars in the skin areas of interest 
- Ability to move independently and to maintain supine and prone positions 
- Able to give written informed consent 
- No use of cosmetic products or topical applied drugs on the study areas at least 12 hours   
before measurement  
- Skin phototype I to III according to Fitzpatrick classification 
- Willing and able to fulfil the study requirements 
 
These criteria are chosen because they reflect the target group and results will be 
comparable with the previous study (Kottner et al. 2015, Dobos et al. 2015). This would 
enhance interpretation. 
 
Exclusion criteria 
- Disability to maintain in supine or prone position 
- Acute diseases 
- Acute or chronic diseases with increased or decreased body temperature (≤ 35°C 
or ≥ 38,5°C, measured in the ear) 
- History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic 
dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD) 
- Acute or chronic wounds in the skin areas of interest 
- Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or 
scar on the investigational sites 
- Participation in another clinical study 4 weeks before inclusion visit  
- Current participation in any other clinical study 
 
3.2 
Interventions 
After giving informed consent and checking the in- and exclusion criteria, the subjects will be 
randomized into three study groups (three different support surfaces): 

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(1) Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA) 
(2) Reactive support surface, gel mattress (IsoGel, stryker, USA) 
(3) Standard mattress (basic foam) 
The support surfaces will be used according to the manufacturer instructions. Every subject 
will lie on every mattress. Therefore, every subject will have at least three visits in the study 
center of approximately 4 hours. The order of mattress use will be randomized for the visits. 
 
The study volunteers will be requested, to acclimatize for 30 min at 40-60% relative humidity 
and a temperature of 20-22°C with having the right lateral heel, sacral and sternal skin 
uncovered. During this time the right lateral heel skin, the sacral and sternal skin will be 
marked in prone position. Once in prone position the baseline skin measurements on the 
right lateral heel and sacral skin will be conducted (order see below: Sequence of 
measurements), that no/minimal interferences between measurements occur (Kottner et al. 
2014). After that, the participants will stay in supine position for two hours. The baseline 
sternal skin measurements will be performed immediately after the subjects turned into 
supine position. At the end of two hours the sternal skin measurements will be repeated. 
After two hours, the subjects turn into prone position again and the skin measurements on 
the right lateral heel and sacral skin will be conducted again to capture the effect of the two 
hour loading on the mattress. The measurements will be repeated after 20 min to observe 
the adjustments after offloading. Study procedures and measurements will be conducted 
always and only in the morning to minimize possible circadian influences. The procedures 
will be performed on all visits in the same way and order, only the support surface will 
change. 
 
Sequence of measurements: 
(1) TEWL  
(2) Skin surface temperature 
(3) Stratum corneum hydration (SCH) 
(4) Erythema  
(5) Epidermal and dermal hydration  
(6) Skin elasticity  
(7) Skin roughness 
(8) Taking of OCT images (only for standard mattress (basic foam))  
 
Measurements will be performed two times per measurement area. Every value will be 
recorded separately. 

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3.3 
Outcomes and variables 
Because this is an exploratory study, no distinction will be made between primary and 
secondary outcomes. 
 
Table 1. Outcomes  
Name  
Method and metric  
Time points of 
data collection  
TEWL 
⋅ Tewameter TM 300 (Courage + Khazaka, Cologne, 
Germany) 
⋅ Means of duplicate measurements per skin area in 
g/m2/h 
BL, after 2 hours 
and 20 minutes 
after loading 
Erythema 
⋅ Mexameter MX 18 
⋅ Means of duplicate measurements per skin area in 
arbitrary units 
BL, after 2 hours 
and 20 minutes 
after loading 
SCH 
⋅ Corneometer CM 825 (Courage + Khazaka, Cologne, 
Germany) 
⋅ Means of duplicate measurements per skin area in 
arbitrary units 
BL, after 2 hours 
and 20 minutes 
after loading 
Skin 
roughness  
⋅ Visioscan VC 98 
⋅ Images of skin structure 
⋅ Rz and Ra in μm 
BL, after 2 hours 
and 20 minutes 
after loading 
Skin elasticity/ 
deformability   
⋅ Cutometer MPA 580 (Courage& Khazaka, Germany) 
⋅ Means of duplicate measurements per skin area in 
mm 
 
BL, after 2 hours 
and 20 minutes 
after loading 
Skin surface 
temperature 
⋅ Measurement with Skin-Thermometer ST 500 
⋅ (Courage+Khazaka electronic GmbH) 
⋅ Means of duplicate measurements per skin area in °C 
per skin area 
BL, after 2 hours 
and 20 minutes 
after loading 
Epidermal and 
dermal 
hydration 
⋅ Measurement with MoistureMeterEpiD (Delfin 
Technologies) 
⋅ Percentage of tissue water (0-100%) (0,5mm 
measurement depth) 
BL, after 2 hours 
and 20 minutes 
after loading 
Epidermal/ 
dermal 
characteristics 
(only for basic 
foam) 
⋅ OCT (Thorlabs, Lübeck, Germany), image processing 
and measurements according Trojahn et al. 2015 
⋅ Descriptive 
BL and after 2 
hours 
Skin thickness 
(only for basic 
foam) 
⋅ OCT (Thorlabs, Lübeck, Germany), image processing 
and measurements according Trojahn et al. 2015 
⋅ μm (metric) 
BL and after 2 
hours 
 

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Table 2. Variables 
Name  
Method and metric 
Time points  
Age 
Checking by looking at the ID card 
(metric) 
Inclusion 
Body temperature  
Clinical thermometer  in °C 
BL, after two hours 
Heart rate 
Beats per minute (bpm) 
BL, after two hours 
Blood pressure 
Millimeters of mercury (mmHg) 
BL, after two hours 
BMI (body height, 
weight) 
kg/m2 
Inclusion 
Phototype 
Categories I, II, III 
Inclusion 
 
 

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3.4 
Participant timeline 
Table 3. Participant timeline  
 
Inclusion 
V1, V2, V3* 
 
0 to 30 min 
30 min 
(acclimatizatio
n) 
Baseline 
measurements 
2 hours  
(supine 
position) 
Prone position 
Prone position 
after 20 
minutes  
In-/exclusion criteria 
x 
 
 
 
 
 
Signed Informed consent 
x 
 
 
 
 
 
Demographics 
x 
 
 
 
 
 
BMI 
x 
 
 
 
 
 
Physical examination 
x 
 
 
 
 
 
Marking of measurement areas 
x 
 
 
 
 
 
Randomization  
x 
 
 
 
 
 
Heart rate 
x 
 
 
 
 
 
Blood pressure 
x 
 
 
 
 
 
Body temperature 
x 
 
 
 
 
 
Skin measurements at sternal skin 
 
 
x 
x 
 
 
Skin measurements at right heel and 
sacral skin 
 
 
x 
 
x 
x 
Adverse events monitoring 
 
x 
x 
x 
x 
x 
*same protocol on V1, V2, V3 (only change of support surface depending on randomized order), V3: end of study 
 

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3.5 
Sample size 
Due to the explorative nature of this study, a formal sample size estimation is not performed. 
However, considering the data of the previous study on a standard hospital mattress (Kottner 
et al. 2015) with n = 15, it is for instance possible, to detect a true difference in mean TEWL 
changes of approx. -8 or 8 g/m2/h with a probability of (power) 0.8 (alpha-level = 0.05) with 
an assumed standard deviation of 10 g/m2/h. Observed TEWL changes at the heel skin were 
actually higher. Therefore we assume that the chosen sample size is sufficient to detect 
differences in support surface performance if they exist.  
 
3.6 
Recruitment 
Potentially relevant subjects will be invited directly to participate by using the subject data 
base of the Clinical Research Center for Hair and Skin Science. The volunteers will be 
contacted by telephone. 

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4 
Methods: assignment of interventions  
 
4.1 
Assignment of interventions 
The subjects will be randomized into one of six possible randomization orders (Table 4). 
 
Table 4. Randomization orders  
1. 
2. 
3. 
4. 
5. 
6. 
Mattress 
A 
Mattress 
A 
Mattress 
B 
Mattress 
B 
Mattress 
C 
Mattress 
C 
Mattress 
B 
Mattress 
C 
Mattress 
A 
Mattress 
C 
Mattress 
A 
Mattress 
B 
Mattress 
C 
Mattress 
B 
Mattress 
C 
Mattress 
A 
Mattress 
B 
Mattress 
A 
 
A = Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA) 
B = Reactive support surface, gel mattress (IsoGel, stryker, USA) 
C = Standard mattress (basic foam) 
 
4.2 
Allocation concealment 
Sequentially numbered opaque sealed envelopes containing the group assignment will be 
prepared and used. Envelope preparation will be done by the data manager of the CRC who 
is not involved in any study preparation or procedures at this stage. 
 
4.3 
Allocation implementation 
The batch of sequentially numbered envelopes is stored at the CRC. Envelopes are opened 
after confirming eligibility and provision of informed consent. 
 
4.4 
Blinding 
Due to the nature of the intervention study assistants and researchers will not be blinded. 
The data manager and statistician will be blinded. 

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5 
Methods: data collection, management, analysis  
 
5.1 
Data collection and management 
All data collectors will be trained in obtaining accurately the variables of interest (see 3.3). 
Paper source data (SD) will be used to document all study variables of interest. The data 
manager creates an SPSS file and data of the SD are entered (single data entry). After data 
are entered, a random subset will be verified by an independent person (SD verification) who 
was not involved in the data entry so far. 
 
5.2 
Statistical methods 
Depending on the level of measurement (nominal, ordinal, continuous) variables will be 
described using absolute and relative frequencies or arithmetic means, medians and spread 
parameters (minimum, maximum, interquartile ranges, standard deviations). Statistical 
analyses will be primary descriptively including group comparisons for dependent samples. 
 

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6 
Methods: monitoring 
 
6.1 
Data monitoring 
Data monitoring is not planned. 
 
6.2 
Harms 
Harms, like pain, persisting erythema for more than 30 minutes or possible irritant reactions, 
which occur immediately or after loading will be documented as an adverse event.  
 
Within this trial the following definitions of adverse events will be used: 
Device Deficiency (DD) 
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. All 
Device Deficiencies that could have led to a Serious Adverse Device Effect shall be reported 
in accordance with Serious Adverse Event reporting procedures. 
 
Adverse Events (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device. 
Note: This definition includes events related to the investigational medical device or the 
comparator. This definition includes events related to the procedures involved. For users or 
other persons, this definition is restricted to events related to investigational medical devices. 
 
Adverse Device Effect (ADE) 
Adverse Event related to the use of an investigational medical device. 
Note: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, installation, implantation, or operation, or any malfunction of 
the investigational medical device. This definition includes any event resulting from use error 
or from intentional misuse of the investigational medical device. 
 
Serious Adverse Event (SAE) 
Adverse Event that: 

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i. leads to death; 
ii. leads to a serious deterioration in the health of the subject, that either resulted in; 
a.  
a life-threatening illness or injury, or 
b.  
a permanent impairment of a body structure or a body function; or 
c.  
prolonged hospitalization; or, 
d.  
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function;  
 
Serious Adverse Device Effect (SADE) 
Adverse Device Effect that has resulted in any of the consequences characteristic of a 
Serious Adverse Event. 
 
According to the Guidelines on Medical Devices (European Commission 2010) the above 
listed definitions only apply for non-CE marked devices and Conformité Européenne CE 
marketed devices outside the intended use. The support surfaces used in this study are 
already CE marketed and are used within the intended use. Therefore formal reporting 
modalities do not apply. However, (1) SAEs and (2) DD that might have led to a SAE will be 
reported not later than 2 calendar days to the manufacturer using the reporting form in 
Appendix 1. 

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7 
Ethics and dissemination  
 
7.1 
Research ethics approval 
The trial protocol and any amendments are prepared in accordance with the Declaration of 
Helsinki in the version of October 1996 (48th General Assembly of the World Medical 
Association, Somerset West, Republic of South Africa) and according to the SPIRIT 
guidance (Chan et al. 2013). This protocol and the informed consent form will be reviewed 
and approved by the responsible ethics committee. This study involves medical devices 
classes I and IIb. Because the product is CE certified already an application to the 
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) is not needed (see MPG-Law § 
23b). An approval to conduct the study will be obtained from the local ethics committee of the 
Charité-Universitätsmedizin Berlin. 
This study inclusion procedure is considered ethically sound, because adverse events by 
using low pressure mattress with low air loss function or gel mattress at heels and the sacral 
skin to prevent skin ulcerations have not been reported so far.  
 
7.2 
Protocol amendments  
The ethics committee will be informed about possible study amendments. 
 
7.3 
Consent 
Subjects meeting the inclusion criteria must provide written informed consent prior to 
participation. The informed consent form (ICF) will meet the requirements proposed by the 
ethics committee of the Charité. Any study participants can withdraw her consent at any time 
without giving reasons. 
 
7.4 
Confidentiality 
All personal data are collected under pseudonymization. Each patient gets a distinct subject 
number. The investigator administrates the subject identification list which includes the 
subject number as well as name, birthday, and address of the subject. The access to this is 
limited, only the investigators as well as the authorized study staff, will have permission to 
inspect this list. All study-related information will be stored securely at the CRC. All 
participant information will be stored in locked file cabinets in areas with limited access. 
Digital data are stored on a secured digital server of the Charité-Universitätsmedizin Berlin. 
 

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7.5 
Declaration of interests  
Related to this PU trial the following possible conflicts of interests are disclosed:  
• JK is member of the EPUAP executive board.  
All other study team members have no possible conflicts of interest regarding PU research to 
declare. 
 
7.6 
Access to data  
Because this is an IIS, the data is owned by the responsible researcher and therefore has full 
access. 
 
7.7 
Dissemination policy 
A clinical study report will be prepared regarding relevant headings of the ICH E3 guideline. 
The study results will be presented in an international scientific journal following the guidance 
of the CONSORT 2010 statement (Schulz et al. 2010). 
 

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8 
References 
Clarke M, Williamson P. Core outcome sets and trial registries. Trials. 2015;16(1):216. 
Dobos G, Gefen A, Blume-Peytavi U, Kottner J. Weight-bearing-induced changes in the 
microtopography and structural stiffness of human skin in vivo following immobility periods. 
Wound Repair Regen. 2015;23(1):37-43. 
Gefen A. How do microclimate factors affect the risk for superficial pressure ulcers: a 
mathematical modeling study. J Tissue Viability. 2011;20(3):81-8. 
Kottner J, Dobos G, Andruck A, Trojahn C, Apelt J, Wehrmeyer H, Richter C, Blume-Peytavi 
U. Skin response to sustained loading: A clinical explorative study. J Tissue Viability. 2015 
May. [Epub ahead of print] 
Kottner J, Gefen A. Incidence of pressure ulcers as primary outcomes in clinical trials: a 
comment on McInnes et al. (2012). Int J Nurs Stud. 2012;49(3):372-4. 
Kottner J, Ludriksone L, Garcia Bartels N, Blume-Peytavi U. Do repeated skin barrier 
measurements influence each other's results? An explorative study. Skin Pharmacol Physiol. 
2014;27(2):90-6. 
National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, Pan 
Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Clinical 
Practice Guideline. Emily Heasler (Ed.). Cambridge Media: Osborne Park, Western Australia; 
2014. 
Nixon J. Outcomes for Pressure Ulcer Trials (OUTPUT). Comet-database. Retrieved from 
http://www.comet-initiative.org/studies/details/283 
Rogiers V; EEMCO Group. Skin Pharmacol Appl Skin Physiol. 2001;14(2):117-28. EEMCO 
guidance for the assessment of transepidermal water loss in cosmetic sciences. 
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated 
guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 
10.1136/bmj.c332. 
 
 

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Appendix 1. SAE reporting form
 

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Appendix 2. Setting of the IsoAir mattress (Stryker) 
 
 

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