Comparing the Effects of Three Different Dressings on the Cutaneous Response to Pressure and Shear of Sacral Skin: an Exploratory Crossover Study
Phase: NA
Conditions: Pressure Ulcer Prevention
Sponsor: Charite University, Berlin, Germany

 
 
CHARITÉ –  UNIVERSITÄTSMEDIZIN BERLIN 
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 
KLINIK FÜR DERMATOLOGIE,  
VENEROLOGIE UND ALLERGOLOGIE 
 
Klinikdirektor: Prof. Dr. med. K. Ghoreschi 
 
Charitéplatz 1 | 10117 Berlin 
 
 
 
Klinik mit zertifiziertem 
Qualitätsmanagementsystem nach 
DIN EN ISO 9001:2015 
 
CLINICAL RESEARCH CENTER FOR HAIR AND SKIN SCIENCE 
Leitung: 
Prof. Dr. med. U. Blume-Peytavi 
   
PD Dr. med. A. Vogt / PD Dr. rer cur. J. Kottner 
Tel:  +49 30 450 518 122 (Sekretariat Forschung)  
Tel.:  +49 30 450 518 178 (Studientelefon) 
Fax:  +49 30 450 518 952 / 998 
https://crc.charite.de/ https://derma.charite.de/ 
 
 
Charité  Campus Mitte  10098 Berlin 
  
 
 
 
 
 
 
 
Berlin, 18.10.2018 
 
 
 
CONFIDENTIAL 
 
 
Protocol 
 
 
Comparing the effects of three different dressings on the cutaneous 
response to pressure and shear of sacral skin: an exploratory 
crossover study 
 
Code: CRC-SP-A-32 
 
Protocol Version 2, 15. January 2019 
 
 
SPONSOR and INVESTIGATORS
FINANCIAL SUPPORT
Jan Kottner, MA, PhD 
Annika Vogt, MD, PhD 
Clinical Research Center for Hair and Skin Science, 
Department of Dermatology and Allergy,  
Charité – Universitätsmedizin Berlin 
Charitéplatz 1, 10117 Berlin, Germany
Mölnlycke Health Care AB 
Box 130 80 
402 52 Gothenburg 
Sweden 
 
PROTOCOL DEVELOPMENT 
 
TRIAL MANAGEMENT 
Anna Lechner, MPH 
Jan Kottner, RN, MA, PhD 
Annika Vogt, MD, PhD 
Sabrina Hadam 
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
Anna Lechner
 
 

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1. Administrative Information 
 
1.1. Title 
Comparing the effects of three different dressings on the cutaneous response to pressure 
and shear of sacral skin: an exploratory crossover study. 
 
1.2. Trial registration 
To be done after approval by the Ethics Committee at clinicaltrials.gov. 
 
1.3. Protocol version 
Version 1 
 
1.4. Financial support 
Mölnlycke Health Care AB 
Box 130 80 
402 52 Gothenburg 
Sweden 
 
1.5. Roles and responsibilities 
Sponsor and principle investigator 
Jan Kottner, PhD 
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 7618 229 
Email: jan.kottner@charite.de 
 
Manufacturer/supplier of the study products 
Mölnlycke Healthcare AB. 
Göteborg, Sweden 
 
Protocol development 
Anna Lechner, MPH 
Jan Kottner, PhD 
Annika Vogt, MD, PhD 
Sabrina Hadam 
 
 
 

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Monitoring 
Charité Coordinating Center for Clinical Studies 
 
Reinickendorfer Straße 61, 13347 Berlin, Germany 
Phone: +49 30 450 553 016 
Fax: +49 30 450 553 937 
Email: kks@charite.de 
 
Trial statistician 
Andrea Stroux 
Department of Biometry and Clinical Epidemiology 
Charité-Universitätsmedizin Berlin, Berlin, Germany  
Charitéplatz 1, 10117 Berlin, Germany 
Phone: +49 30 8445 32 62 / 450 562 155 
Fax: +49 30 8445 4471 
Email: andrea.stroux@charite.de 
 
Laboratory 
Clinical Research Center for Hair and Skin Science 
Department of Dermatology and Allergy,  
Charité – Universitätsmedizin Berlin 
Charitéplatz 1, 10117 Berlin, Germany 
 

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2. 
Introduction 
2.1 Background and Rationale 
 
Pressure ulcers (PUs), also called pressure injuries, are severe and unwanted cutaneous 
lesions and subcutaneous wounds caused by prolonged skin and underlying soft tissue 
deformation. In the supine position they predominantly occur near to bony prominences such 
as heels and the sacrum. The cornerstone of PU prevention is repositioning, early 
mobilization and the use of special support surfaces (National Pressure Ulcer Advisory Panel 
(NPUAP), European Pressure Ulcer Advisory Panel (EPUAP), Pan Pacific Pressure Injury 
Alliance (PPPIA) 2014). 
In addition, empirical evidence suggests that the application of preventive dressings 
on PU predilection sites helps to prevent PU development (Clark et al. 2014). This is 
supported by results of a number of recent clinical trials (e.g. Santamaria et al. 2015, 
Kalowes et al. 2016, Forni et al. 2018) and is now also recommended in the latest Pressure 
Ulcer Prevention and Treatment Guideline (NPUAP, EPUAP, PPPIA 2014). The mode of 
action of PU preventive dressings includes mechanical cushioning and the reduction of shear 
loads within soft tissues and the reduction of the coefficient of friction between the dressing 
and the support surface (Call et al. 2015, Levy et al. 2015, 2017). 
Many different dressings are on the market and the dressing performance is related 
to its material and structure. Results of in vitro, computer modelling, and in vivo studies 
indicate different effects on the skin microclimate, pressure reduction, and maybe also on 
clinical outcomes (e.g. Call et al. 2013, Dutra et al. 2015, Matsuzaki et al. 2015). However, 
results of laboratory or computer modelling studies are not automatically transferable to real-
life situations. In addition, there are no high quality clinical trials with a direct head-to-head 
comparison of the most important competitors on the market. Therefore, it is not appropriate 
to generalize clinical study results of one dressing type to another (Gefen et al. 2016). 
Next to the ‘hard’ clinical outcome ‘PU development’ there are a number of alternative 
biomarkers and parameters to characterize the response of the skin to prolonged loading 
and deformation. According to Bader and Worsley (2018) they may be classified into four 
categories: (1) ‘Monitoring of the interface’ (including interface pressure mapping, shear, 
friction and microclimate measurement); (2) ‘Biophysical skin sensing’ (skin measurements); 
(3) ‘Biomarkers indicative of early skin damage’ (for example cytokines, chemokines, lactate 
on the skin surface, blood markers such as CRP); (4) ‘Medical imaging’ (including MRI, CT, 
ultrasound, colour measurements). Skin functional parameters such as erythema or stratum 
corneum hydration and structural parameters, like structural stiffness, have been 
successfully used in PU prevention research (Dobos et al. 2015, Kottner et al. 2015). These 
parameters are able to discriminate effects of different loading intensities and to measure PU 
preventive device performance (Tomova-Simitchieva et al. 2017). Recently it also could be 

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shown that there are associations between structural and functional skin changes at the heel 
and sacral area during loading (Pfannes et al. 2018). 
(Subclinical) injuries to the stratum corneum stimulate the production of inflammatory 
cytokines. In clinical PU research, it has been shown that levels of IL-1alpha are also useful 
to measure the inflammatory response of the skin due to mechanical deformation. It was 
demonstrated that the increase of cytokines is related to mechanical loading intensity (De 
Wert et al. 2016, Bader, Worsley 2018) and thus are suitable biomarkers to measure early 
skin response due to deformation. 
Recently, Mölnlycke Healthcare sponsored a study to investigate the effects of 
pressure ulcer preventive dressings on loaded and unloaded skin. Between July and October 
2016 n = 8 healthy males (mean age 28 years) were included into an exploratory cross-over 
trial to explore the effects of Mepilex® Border Sacrum and Heel on the sacral and heel skin 
with and without loading (CRC-SP-A-26). Main results were that the dressings have an 
occlusive effect in terms of accumulation of heat and humidity, but this was not very different 
to loaded skin without dressings. This increase of stratum corneum and epidermal hydration 
softened the skin and contributed to changes of skin topography. Finally, results indicate that 
loading increased the inflammatory cytokine IL-1alpha and that this increase seemed to be 
slightly lower when a dressing was applied. This may indicate that the dressing may reduce 
the inflammatory response. The detailed results are reported in the full study report version 
2, December 2016. 
Overall, the study results indicate that cutaneous structure and function parameters 
can characterize the response of heel and sacral skin due to loading and that it is possible to 
measure a particular dressing effect. However, the sample size was small, the loading 
duration of 2.5 hours was short, shear forces were reduced to a minimum, and the sample 
was not representative for patients at PU risk. Therefore, there is a need to repeat this study 
using a more relevant target group such as aged females, to increase the mechanical 
loading in terms of pressure and shear, and to compare directly different dressing types. 
 
2.2 Aims 
The overall aim of this study is to measure the effects of Mepilex® Border Sacrum on the 
skin structure and function during mechanical loading compared to (1) no dressing, 
(2) ALLEVYN Life Sacrum and (3) Optifoam® Gentle Liquitrap Sacrum. 
 
The following objectives are determined: 
(1) To measure the changes of skin temperature, stratum corneum hydration, erythema and 
skin roughness, (2) to evaluate clinical signs of pain and erythema and (3) to determine  
IL-1alpha and total protein of the sacral skin before loading (baseline) and after three and a 

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half hours loading with or without application of a dressing (Mepilex® border, ALLEVYN Life 
Sacrum, Optifoam® Gentle Liquitrap Sacrum). 
 
3. Methods: Participants, interventions, and outcomes 
3.1 Study design 
This study is an investigator initiated explorative randomized cross-over trial using 
intraindividual comparisons. In total four interventions will be compared at the sacral skin 
(Table 1).  
3.2 Study setting 
The study will be conducted at the Clinical Research Center for Hair and Skin Science (CRC) 
at the Department of Dermatology and Allergy, Charité – Universitätsmedizin Berlin. 
3.3 Eligibility criteria 
Inclusion criteria 
• Healthy female volunteers 
• 65 to 80 years 
• Body Mass Index 18.5 to 29.9 kg/m2 
• Non-smoker of at least one year (including electronic-cigarettes) 
• Informed consent 
• Being free of any clinical dermatosis in the investigational area 
• Intact sacral skin without scars 
• Skin phototype I, II, or III (according to Fitzpatrick) 
• No regular use of leave-on products on the sacral skin 
• Willing and able to fulfil the study requirements 
 
Exclusion criteria 
• Disability to maintain in supine or prone position 
• Acute diseases 
• Known hyper-sensibility or allergy to the study product or any of its ingredients 
• Extensive UV exposure 4 weeks before study inclusion 
• Use of topical treatment on the investigational areas or systemic treatment within the 4 past 
weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, NSIDS etc.) that 
would interfere with assessment and/or investigational treatments 
• Medical history of skin cancer 
• History of established Diabetes mellitus, cardiac or renal insufficiency, COPD 

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• Chronic inflammatory skin disorders such as atopic dermatitis, psoriasis, lichen planus 
• Participation in another study 4 weeks prior to study start 
 
3.4 Study procedures and interventions 
 
Volunteers will come to the study centre for four visits. In between, there are at least 3 weeks 
to prevent possible carry over effects. Therefore, the entire duration of one subject will be at 
least 9 weeks. The duration of one study visit per subject is approximately 5 hours. After four 
visits, each volunteer will have received each intervention once (A, B, C and D, see Table 1).  
 
Table 1. Experimental interventions for the sacral skin 
Intervention 
Dressing 
A 
None 
B 
Mepilex® Border Sacrum 
C 
ALLEVYN Life Sacrum  
D 
Optifoam® Gentle Sacrum 
 
After giving informed consent, subjects will lie down in supine position on a standard hospital 
mattress for a maximum of 10 minutes. Then subjects will turn around into prone position. 
Two fields of equal size (each 2cm x 2.5cm) will be marked with a skin pen, one for the 
baseline and one for the follow-up measurements. If an erythema has occurred at the sacral 
area during the 10 minutes in supine position, the investigational site will be marked within 
the reddened skin area. In case of no erythema, the test area will be identified by feeling the 
most protuberant point at sacrum. After marking the measurement area the subjects will 
acclimatize under standardized room temperature and humidity conditions (22±2°C, 40 to 
60% rel. humidity) for 30 minutes with having the sacral skin uncovered. Subjects may lay 
(on the side) or sit during this period but must make sure that the investigational area is 
uncovered. After that, subjects will move into prone position and the following baseline 
measurements will be conducted according to CRC standard operating procedures (SOPs): 
(1) Measurement of skin surface temperature 
(2) Measurement of SC hydration (SCH) 
(3) Measurement of Erythema index (EI) 
(4) Visioscan images to measure Rz, Ra 
(5) Cyanoacrylate skin surface stripping (CSSS), to determine IL-1alpha and total protein of 
the sacral skin.  
In addition to the instrumental measurements, erythema and pain will be evaluated clinically. 

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The measures of skin surface temperature, SCH and EI will be performed three times per 
measuring round. Two duplicate Visioscan images will be taken. CSSS will be performed at 
the end. 
After the baseline measurements a randomization envelope will be opened to allocate 
the subject to one of the intervention groups A, B, C or D (see Table 1). The dressings (B, C, 
D) will be applied or the skin will be left uncovered (A), followed by a 3.5 hours loading 
period. The subject will lie in supine position on a standard hospital mattress. Every 30 
minutes the head of the bed will be elevated to 45° for five minutes. During these five 
minutes, the participants will be instructed to bend their knees and to drag the feet repeatedly 
forth and back 10 times. Then the head of bed will be moved back again and the subjects 
can relax. The whole exercise will be done six times, after 0.5, 1, 1.5, 2, 2.5 and 3 hours. 
After 3.5 hours loading time in supine position the subjects will move into prone 
position. In case of interventions B, C or D the dressings will be removed. Then all skin 
measurements and CSSS will be conducted again. After the end of the measurements and 
procedures, subjects will leave the study site. They will come back for another three times 
completing the remaining interventions.  

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3.5 Participant timeline 
 
Table 2. Individual participant timeline per visit 
Hours 
0.0 
0.5 
1.0 
1.5 
2 
2.5 
3.0 
3.5 
4.0 
4.5 
5.0 
5.5 
In-/exclusion criteria1 
x 
 
 
 
 
 
 
 
 
 
 
 
Informed consent1 
x 
 
 
 
 
 
 
 
 
 
 
 
Demographics1 
x 
 
 
 
 
 
 
 
 
 
 
 
Medical examination1 
x 
 
 
 
 
 
 
 
 
 
 
 
Skin inspection1 
x 
 
 
 
 
 
 
 
 
 
 
 
Supine position for 10 
minutes 
x 
 
 
 
 
 
 
 
 
 
 
 
Marking of investigational 
areas 
 
x 
 
 
 
 
 
 
 
 
 
 
Acclimatization for 30 
minutes with sacrum 
uncovered 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
 
Randomization of 
treatments 
 
 
x 
 
 
 
 
 
 
 
 
 
Supine position 
 
 
 
 
 
 
 
 
 
 
 
 
Elevation of head of bed, 
bending knees and moving 
heels on the mattress back 
and forth 10x 
 
 
 
 
x 
x 
x 
x 
x 
x 
 
 
Clinical evaluation 
 
Pain 
 
 
 
 
 
 
 
 
 
 
 
 
Erythema 
 
 
x 
 
 
 
 
 
 
 
x 
 
Measurements 
 
SCH 
 
 
x 
 
 
 
 
 
 
 
x 
 
Erythema index 
 
 
x 
 
 
 
 
 
 
 
x 
 
Skin surface temperature 
 
 
x 
 
 
 
 
 
 
 
x 
 
Visioscan Rz, Ra 
 
 
x 
 
 
 
 
 
 
 
x 
 
CSSS (Cytokines IL-1, total 
protein)  
 
 
x 
 
 
 
 
 
 
 
x 
 
Adverse events monitoring 
and documentation 
 
 
 
 
 
 
 
 
 
 
 
 
1Inclusion visit only 

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3.6 Variables and outcomes 
Due to the explorative nature of this study, no distinction between primary, secondary or 
other variables is made (Table 3). 
 
Table 3. Variables and outcomes 
Name 
Method and metric 
Skin phototype 
• Classification according to Fitzpatrick (nominal) 
Height 
• Measurements in the CRC 
• m (metric) 
Weight 
• Measurements in the CRC 
• kg (metric) 
Age 
• Checking by looking at the ID card 
• metric 
Sacral pain 
• Subjects’ self-report 
• Pain (yes/no) (nominal) 
• Time to pain reporting in minutes (metric) 
Erythema 
• Visual inspection 
• VAS (metric) 
Skin surface 
temperature  
• Skin thermometer based in infrared technique (Courage and Khazaka 
Electronic GmbH) 
• °C (metric) 
SCH 
• Noninvasive instrumental measure using the Corneometer CM 825 (Courage 
and Khazaka Electronic GmbH) 
• Arbitrary units, A.U. (metric) 
EI 
• Noninvasive instrumental measure using the Mexameter  MX18 (Courage and 
Khazaka Electronic GmbH) 
• Arbitrary units, A.U. (metric) 
Rz, Ra, Rmax 
• Visioscan VC 98 (Courage and Khazaka Electronic GmbH) 
• µm (metric) 
Cytokines 
• Cyanoacrylate skin surface stripping (CSSS) (or another sampling method) 
• IL-1, total protein in pg/µg 
• ELISA 
 
3.7 Sample size 
Due to the exploratory nature of this trial a formal sample size calculation is not performed. 
We plan to include n = 12 female subjects. 
3.8 Recruitment 
Potentially relevant subjects will be invited directly to participate by using advertisement 
and/or announcements 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 
After the baseline measurements are completed, opaque envelopes will be opened to assign 
the treatment order. In order to minimize bias, the product allocation will be randomized. A 
computerized simple 1:1:1:1 randomization scheme for four study visits will be applied for the 
sacral skin for n = 12 subjects. An example of a possible allocation is displayed in Table 4. 
 
Table 4. Example for order of experimental interventions for the sacral skin 
Subject number 
Dressing application order visits 1, 2, 3, 4 
1 
C → A → D → B 
2 
B → D → C → A  
3 
A → C → D → B 
4 
D → A → B → C 
5 
B → A → C → D 
6 
A → C → B → D 
7 
B → C → A → D 
8 
… 
9 
… 
10 
… 
11 
… 
12 
C → B → D → A 
 
4.2 Allocation concealment 
During the trial preparation the data manager, who is not involved in the trial and uses 
appropriate software, will create this randomization scheme independently. The scheme will 
not be revealed to the investigators. Sequentially numbered opaque sealed envelopes 
containing the randomized intervention order will be used. 
4.3 Allocation implementation 
The batch of sequentially numbered envelopes is stored at the CRC. Envelopes are opened 
after confirming eligibility, provision of informed consent and after the first baseline 
measurement. 
4.4 Blinding  
Due to the nature of the intervention subjects, study assistants, and researchers will not be 
blinded. The data manager will be blinded. Emergency unblinding is not foreseen. 
 
 

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5 Methods: data collection, management, analysis 
5.1 Data collection and management 
All study data will be recorded on paper source data and subsequently entered into an 
electronic database. After data are entered, a random subset will be verified by an 
independent person (source data verification) who was not involved in the data entry. All 
aspects of Data Management is managed by properly trained staff at Charité. 
5.2 Statistical methods 
Demographic characteristics will be described using numbers, proportions, means and 
standard deviations. Metric outcomes will be described using mean and spread parameters 
per intervention and time point. Baseline and follow-up parameters will be compared 
descriptively.   
6 Methods: monitoring 
6.1 Monitoring 
One monitoring visit will be done by the Charité Coordinating Center for Clinical Studies, 
comprising the following tasks: 
• 
Checking the existence of study participants 
• 
 Checking the existence of informed consents  
• 
Checking the completeness of the source data for one study participant 
6.2 Harms 
Harms, like pain, persisting erythema lasting 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. 
 
 

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Adverse Event (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: 
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; or 
 
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 silicone dressings 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 
An approval to conduct this study will be obtained from the local ethics committee of the 
Charité-Universitätsmedizin Berlin. 
 
7.2  Protocol amendments 
The ethics committee will be informed about possible study amendments. 
 
7.3 Consent 
Subjects meeting all of the inclusion criteria and none of the exclusion 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 distinctive 
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 Clinical Research 
Center for Hair and Skin Science. All participant information will be stored in locked file 
cabinets in areas with limited access. Electronical data are stored on a secured digital server 
of the Charité. Medical devices are stored securely at the Clinical Research Center for Hair 
and Skin Science in locked rooms in areas with limited access at appropriate temperature 
and humidity. 
 
 

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8. References 
Bader DL, Worsley PR. Technologies to monitor the health of loaded skin tissues. Biomed 
Eng Online. 2018;17(1):40. 
Call E, Pedersen J, Bill B, Oberg C, Ferguson-Pell M. Microclimate impact of prophylactic 
dressings using in vitro body analog method. Wounds. 2013;25(4):94-103. 
Clark M, Black J, Alves P, Brindle C, Call E, Dealey C, Santamaria N. Systematic review of 
the use of prophylactic dressings in the prevention of pressure ulcers. Int Wound J. 
2014; 11(5):460-71. 
de Wert LA, Schoonhoven L, Stegen JHCH, Piatkowski AA, Hulst RRV, Poeze M, Bouvy ND. 
Improving the effect of shear on skin viability with wound dressings. J Mech Behav 
Biomed Mater. 2016;60:505-514. 
Dutra RA, Salomé GM, Alves JR, Pereira VO, Miranda FD, Vallim VB, de Brito MJ, Ferreira 
LM. Using transparent polyurethane film and hydrocolloid dressings to prevent 
pressure ulcers. J Wound Care. 2015;24(6):268-75. 
Forni C, D'Alessandro F, Gallerani P, Genco R, Bolzon A, Bombino C, Mini S, Rocchegiani L, 
Notarnicola T, Vitulli A, Amodeo A, Celli G, Taddia P. Effectiveness of using a new 
polyurethane foam multi-layer dressing in the sacral area to prevent the onset of 
pressure ulcer in the elderly with hip fractures: A pragmatic randomised controlled trial. 
Int Wound J. 2018. [Epub ahead of print] 
Gefen A, Kottner J, Santamaria N. Clinical and biomechanical perspectives on pressure 
injury prevention research: The case of prophylactic dressings. Clin Biomech. 
2016;38:29-34. 
Levy A, Frank MB, Gefen A. The biomechanical efficacy of dressings in preventing heel 
ulcers. J Tissue Viability. 2015;24(1):1-11. 
Levy A, Schwartz D, Gefen A. The contribution of a directional preference of stiffness to the 
efficacy of prophylactic sacral dressings in protecting healthy and diabetic tissues from 
pressure injury: computational modelling studies. Int Wound J. 2017;14(6):1370-1377. 
Kalowes P, Messina V, Li M. Five-Layered Soft Silicone Foam Dressing to Prevent Pressure 
Ulcers in the Intensive Care Unit. Am J Crit Care. 2016;25(6):e108-e119. 
National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan 
Pacific Pressure Injury Alliance. Prevention and treatment of pressure ulcers: clinical 
practice guideline. Emily Haesler (ed.). Washington DC: National Pressure Ulcer 
Advisory Panel, 2014. 
Matsuzaki K, Kishi K. Investigating the pressure-reducing effect of wound dressings. J 
Wound Care. 2015;24(11):512-7.  
Santamaria N, Gerdtz M, Sage S, McCann J, Freeman A, Vassiliou T, De Vincentis S, Ng 
AW, Manias E, Liu W2, Knott J. A randomised controlled trial of the effectiveness of 

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soft silicone multi-layered foam dressings in the prevention of sacral and heel pressure 
ulcers in trauma and critically ill patients: the border trial. Int Wound J. 2015;12(3):302-
8. 
Pfannes EKB, Blume-Peytavi U, Kottner J. Patterns and associations of structural and 
functional cutaneous responses during loading at heel and sacral skin in aged females: 
A reanalysis of clinical study data. J Tissue Viability. 2018. [Epub ahead of print] 
Tomova-Simitchieva T, Lichterfeld-Kottner A, Blume-Peytavi U, Kottner J. Comparing the 
effects of 3 different pressure ulcer prevention support surfaces on the structure and 
function of heel and sacral skin: An exploratory cross-over trial. Int Wound J. 2017. 
[Epub ahead of print] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9. Appendix 1: SAE Reporting Form