A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings
Phase: NA
Conditions: Pressure Ulcer
Sponsor: PD Dr. Jan Kottner

 
 
 
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 
A RANDOMIZED CONTROLLED PARALLEL-GROUP TRIAL TO 
INVESTIGATE THE EFFECTIVENESS OF TWO SILICONE DRESSINGS 
FOR SACRAL AND HEEL PRESSURE ULCER PREVENTION 
COMPARED TO NO DRESSINGS 
Code: CRC-PU-A-16 
Version 4, September 29, 2015 
SPONSOR 
INVESTIGATOR 
Clinical Research Center for Hair and Skin Science, 
Department of Dermatology and Allergy, 
Charité – Universitätsmedizin Berlin 
Charitéplatz 1, 10117 Berlin, Germany 
 
On behalf of the Clinical Quality and Risk Management 
Charité – Universitätsmedizin Berlin 
Charitéplatz 1, 10117 Berlin, Germany 
 
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 
 
PROTOCOL DEVELOPMENT 
PROTOCOL REVIEW 
Dr. Jan Kottner 
Prof. Dr. Ulrike Blume-Peytavi 
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 
Armin Hauss 
Dr. Jan Steffen Jürgensen 
Clinical Quality and Risk Management 
Charité-Universitätsmedizin Berlin, Germany 
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-16 
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Table of contents 
 
1 
Administrative Information .............................................................................................. 6 
1.1 
Title ......................................................................................................................... 6 
1.2 
Trial registration ...................................................................................................... 6 
1.3 
Protocol version ...................................................................................................... 6 
1.4 
Funding ................................................................................................................... 6 
1.5 
Roles and responsibilities ........................................................................................ 6 
2 
Introduction .................................................................................................................... 8 
2.1 
Background and Rationale ...................................................................................... 8 
2.2 
Objectives ............................................................................................................... 9 
2.3 
Trial design ............................................................................................................. 9 
3 
Methods: Participants, interventions, and outcomes ......................................................10 
3.1 
Study setting ..........................................................................................................10 
3.2 
Eligibility criteria .....................................................................................................10 
3.3 
Interventions...........................................................................................................12 
3.4 
Outcomes ...............................................................................................................14 
Primary outcome ...........................................................................................................14 
Secondary outcomes .....................................................................................................15 
Other variables ..............................................................................................................16 
3.5 
Participant timeline .................................................................................................18 
3.6 
Sample size............................................................................................................19 
3.7 
Recruitment ............................................................................................................20 
4 
Methods: assignment of interventions ...........................................................................21 
4.1 
Assignment of interventions ...................................................................................21 
4.2 
Allocation concealment ..........................................................................................21 
4.3 
Allocation implementation.......................................................................................21 
4.4 
Blinding ..................................................................................................................21 
5 
Methods: data collection, management, analysis...........................................................22 
5.1 
Data collection and management ...........................................................................22 
5.2 
Statistical methods .................................................................................................23 
6 
Methods: monitoring ......................................................................................................25 
6.1 
Data monitoring ......................................................................................................25 
6.2 
Interim analysis ......................................................................................................25 
6.3 
Harms ....................................................................................................................25 

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6.4 
Auditing ..................................................................................................................26 
7 
Ethics and dissemination ...............................................................................................27 
7.1 
Research ethics approval .......................................................................................27 
7.2 
Protocol amendments ............................................................................................27 
7.3 
Consent ..................................................................................................................27 
7.4 
Confidentiality .........................................................................................................28 
7.5 
Declaration of interests ...........................................................................................28 
7.6 
Access to data ........................................................................................................28 
7.7 
Ancillary and post-trial care ....................................................................................28 
7.8 
Dissemination policy ...............................................................................................28 
8 
References ....................................................................................................................30 
9 
Appendices ...................................................................................................................32 
 
 
 
 

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Study code CRC-PU-A-16 
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List of figures 
Figure 1. Current pressure ulcer prevention standard at the Charité .....................................12 
Figure 2. Expected study flow chart ......................................................................................18 
Figure 3. Data collection and management ..........................................................................23 
 
 

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Study code CRC-PU-A-16 
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Abbreviations 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AQUA 
Institut für angewandte Qualitätsförderung und Forschung 
BfArM 
Bundesinstitut für Arzneimittel und Medizinprodukte 
CC 
CharitéCenters 
CE 
Conformité Européenne 
CEA 
Cost effectiveness analysis 
CIP 
Clinical investigation plan 
CP 
Conditional power 
CRC 
Clinical Research Center for Hair and Skin Science 
CRF 
Case report form 
DD 
Device deficiency 
DTI 
Deep tissue injury 
ED 
Emergency department 
EPUAP 
European Pressure Ulcer Advisory Panel 
ICER 
Incremental cost effectiveness ratio 
ICF 
Informed consent form 
ICU 
Intensive care unit 
IIS 
Investigator initiated study 
LOCF 
Last observation carried forward 
NPUAP 
National Pressure Ulcer Advisory Panel 
PPPIA 
Pan Pacific Pressure Injury Alliance 
PU 
Pressure ulcer 
PUCLAS 
Pressure ulcer classification 
QM 
Clinical Quality and Risk Management 
RR 
Relative risk 
SADE 
Serious Adverse Device Effect 
SAE 
Serious adverse event 
SD 
Source data 
SOP 
Standard operating procedure 
TMF 
Trial master file 
 

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Study code CRC-PU-A-16 
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1 
Administrative Information 
 
1.1 
Title 
A randomized controlled parallel-group trial to investigate the effectiveness of two silicone 
dressings for sacral and heel pressure ulcer prevention compared to no dressings 
 
1.2 
Trial registration 
The study is registered at https://clinicaltrials.gov/. The ClinicalTrials.gov Identifier is 
NCT02295735. 
 
1.3 
Protocol version 
Version 4 of September 29, 2015 
 
1.4 
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. on behalf of the Central Quality Management (QM) of the Charité-Universitätsmedizin 
Berlin. The trial is supported by Mölnlycke Healthcare AB. Mölnlycke provides the silicone 
dressings Mepilex® Border Sacrum and Mepilex® Border Heel for the intervention group. 
 
1.5 
Roles and responsibilities 
Sponsor and principle 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 
Phone: +49 30 450 518 218 
Fax: +49 30 450 7618 229 
Email: jan.kottner@charite.de 
 
Project leader and scientific contact 
Dr. Jan Kottner 
Clinical Research Center for Hair and Skin Science 
Department of Dermatology and Allergy 

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Study code CRC-PU-A-16 
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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 
Mölnlycke Healthcare AB 
Göteborg, Sweden 
Contact person 
Jill McLean  
Global Therapy Manager - Pressure Ulcers  
Molnlycke Health Care 
Phone: +46739412656 
Email: Jill.Mclean@molnlycke.com 
 
Protocol development 
Dr. Jan Kottner 
Annette Andruck 
Elisabeth Hahnel 
Prof. Dr. Ulrike Blume-Peytavi 
 
Protocol review 
Armin Hauss 
Clinical Quality and Risk Management 
Charité-Universitätsmedizin Berlin, Germany 
Phone: +49 30 450529055 
Email: armin.hauss@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 

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Study code CRC-PU-A-16 
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2 
Introduction 
 
2.1 
Background and Rationale 
Pressure ulcers (PUs) are severe forms of skin and tissue lesions caused by prolonged 
compression and deformation of soft tissues. PU prevalence and incidence is high especially 
in high risk settings like geriatric, long-term or intensive acute care. According to the latest 
Global Burden of Disease Study 2010 PUs were assigned the highest disability index (Hay et 
al. 2014). In adults the majority of PU occurs at the heels and at the sacral area (Kottner, 
Raeder 2014). The occurrence of PUs in hospitals is widely accepted as an unwanted 
adverse outcome in patient care. PU incidence and/or hospital acquired PU prevalence are 
widely accepted indicators of the quality of care (Kottner, Lahmann 2013; Unbeck et al. 
2013). In Germany PU incidence figures are regularly used to make country wide 
comparisons of PU prevention and treatment performance in hospitals (AQUA 2012). 
However, effective and efficient PU prevention especially in high risk settings is still 
challenging and there is a high need to optimize prevention further. 
 
PU prevention includes the identification of PU risk and the application of preventive 
measures. Mobility and activity limitations are the most important PU risk factors. 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, there is emerging evidence that the application of dressings on pressure ulcer 
predilection sites may help to prevent PU development (Clark et al. 2014). In the latest 
Pressure Ulcer Prevention and Treatment Guideline the use of prophylactic dressings is 
considered as an emerging preventive intervention (NPUAP, EPUAP, PPPIA 2014). 
Preventive dressings on intact skin might reduce friction and shear forces and/or modify the 
microclimate (Park 2014, Santamaria et al. 2013a). Both mechanisms might protect the skin 
and underlying tissues from pressure/deformation injury. Because this new approach might 
potentially further reduce PU incidence, thus increasing hospital patient safety, the Clinical 
Quality and Risk Management of the Charité-Universitätsmedizin Berlin decided to 
investigate, whether these dressings are also effective at the Charité-Universitätsmedizin 
Berlin.  
 
 
 
 

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2.2 
Objectives 
Primary objective 
• To determine if preventive silicone dressings (Mepilex® border) applied to the heels and to 
the sacrum in addition to PU standard prevention reduce the cumulative PU incidence 
category II, III, IV, and deep tissue injury (DTI) compared to PU standard prevention alone in 
at high or very high risk hospital patients. 
 
Secondary objectives 
• To determine if preventive silicone dressings (Mepilex® border) applied to the heels and to 
the sacrum in addition to PU standard prevention reduce the PU incidence density category 
II, III, IV, and deep tissue injury (DTI) compared to PU standard prevention alone in at high or 
very high risk hospital patients. 
• To determine if preventive silicone dressings (Mepilex® border) applied to the heels and to 
the sacrum in addition to PU standard prevention reduce the cumulative PU incidence 
category I compared to PU standard prevention alone in at high or very high risk hospital 
patients. 
• To determine if preventive silicone dressings (Mepilex® border) applied to the heels and to 
the sacrum in addition to PU standard prevention reduce the PU incidence density category I 
compared to PU standard prevention alone in at high or very high risk hospital patients. 
• To determine if preventive silicone dressings (Mepilex®  border) applied to the heels and to 
the sacrum in addition to PU standard prevention increase days free of PUs category I, and 
category II, III, IV, and DTI compared to PU standard alone in at risk hospital patients. 
• To determine if preventive silicone dressings (Mepilex® border) applied to the heels and to 
the sacrum in addition to PU standard prevention are cost effective. 
 
2.3 
Trial design 
A randomized, controlled, two arm, superiority pragmatic trial will be performed with a 1:1 
allocation to the intervention and control groups. After completion of 50% of the subjects an 
interim analysis will be conducted to allow potential early stopping (futility stopping based on 
conditional power) (see 6.2). 
 

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3 
Methods: Participants, interventions, and outcomes 
 
3.1 
Study setting 
The study will be conducted at the Charité university hospital (Berlin, Germany) in critically ill 
and/or trauma patients who are admitted to the emergency department and/or to intensive 
care units (ICUs). 
 
3.2 
Eligibility criteria 
Inclusion criteria 
• Age 18+ years 
• Major trauma and/or critically ill surgical and/or internal patients (e.g. with cardiac arrest) 
admitted to the emergency department and being transferred and/or admitted or directly to a 
surgical or internal ICU 
• Major trauma and/or critically ill surgical and/or internal patients admitted through an in-
house hospital transfer to a surgical or internal ICU (e.g. postoperative complications or 
acute deterioration of general health) 
• Being at “high” or “very high” PU risk according to the Charité PU prevention standard: 
- Category 3 (=care dependent/limited bed mobility) 
- 4A (= high care depended, limited mobility in bed) 
- 4B (= high care dependent, totally immobile) according to the Jones classification 
modified by Charité 
• Expected minimum length of stay at least three days 
• Informed consent (or by legal representative) 
 
Exclusion criteria 
• Patients at end of life/dying patients 
• Existing PU or other skin/tissue lesion (e.g. scars) at heels or sacral skin 
• Positioning on air fluidized beds 
• Known allergy to Mepilex® dressings 
• Patients who cannot be repositioned due to medical reasons (e.g. cardiovascular instability, 
suspected or actual spinal cord injury) 
• Trauma to sacrum and/or heels 
• Exclusion based on complicated or not possible positioning of patients with the following 
diagnoses (ICD-10-GM version 2015): 66.2; J80.0; S06.-; G93.2; I60.-; I63.- 
• Exclusion due to certain procedures (OPS version 2015): 8-390.0; 8-390.3; 8-390.4; 
8-852  

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Study code CRC-PU-A-16 
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As this study does not involve any drugs, systemic agents or any other invasive techniques, 
patients would be eligible even if they participate in another trial. 
 
 
 

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3.3 
Interventions 
Within the study PU prevention for all patients follows the Charité university hospital pressure 
ulcer prevention standard (Charité-Universitätsmedizin Berlin 2012) (Figure 1). 
 
 
Figure 1. Current pressure ulcer prevention standard at the Charité 
 
 
This includes PU risk scoring and skin inspection within 6 hours after admission and 
depending on the risk categories “high risk” and “very high risk” the implementation of 
preventive measures including: (1) patient information, (2) daily skin inspection, (3) 
mobilization, (4) use of special support surfaces, (5) repositioning and (6) floating heels. 
Regarding general skin and incontinence care there are no other standards implemented at 
the moment. 
 

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In case of potentially meeting the inclusion criteria for the study a researcher/research 
assistant of the CRC team will check the in- and exclusion criteria using a screening form. If 
eligible the assignment to one of the study groups will be performed by this researcher. This 
will be also done within 6 hours after admission to the ICU. 
 
If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and 
Mepilex® Border Heel will be applied by the researcher/research assistant onto the 
respective intact skin areas according to the instructions of the manufacturer and according 
to the study SOP (see Appendices 1 and 2). Special care will be taken that the Mepilex® 
Border Sacrum is carefully applied and that no other skin care products are used between 
the skin and the dressings. The dressings will be renewed every 3 days by the 
researcher/research assistant. In case of becoming soiled or dislodged they are changed 
immediately by the nurses and/or by the researchers. Nurses on the participating ICUs and 
on general wards will be instructed accordingly. In addition, in the intervention group 
laminated patient cards will be posted at and/or near the bed serving as reminder and 
containing minimum information about how to apply the dressings and the contact of the 
responsible researcher (Appendix 3). Dressings remain onto the skin during the whole study 
period also including transfer to another ward. All other PU preventive care and treatment 
procedures are performed as usual according to the Charité PU prevention standard (Figure 
1). 
 
Skin and tissue inspections are conducted and study variables are collected daily by 
instructed researchers/research assistants/study nurses in agreement with the ICU and 
general ward staff. The following educational activities will be conducted before and during 
the trial: 
• Initiation visit/kick-off meeting explaining the study design, procedures, data collection and 
documentation methods 
• One hour skin and PU classification instruction, followed by an online examination 
PUCLAS3 (Beeckman, Schoonhoven 2014) for all study nurses/research assistants doing 
skin examinations 
• Unannounced patient visits by the principle investigator for duplicate data collection and 
skin examination 
 
Research assistants/study nurses/researchers follow up all included patients once daily for 
ensuring study compliance, monitoring correct dressing use and fit, doing skin inspections at 
the heels and sacral area and for monitoring the health condition including daily 

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Study code CRC-PU-A-16 
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documentation of PU risk and resource use regarding dressings and possible PU treatment 
(dressings, wound care procedures). 
 
The study/follow-up ends if: 
• The patient is no longer at “high” or “very high” PU risk according to the Charité standard 
(Figure 1) and if no sacral or heel PU developed or 
• Complete healing of a within the study period developed heel or sacral PU or 
• An adverse event (AE) related to the preventive dressings occurred or 
• The patient wishes to withdraw or 
• A severe form of protocol violation occurred (e.g. non-wearing of the dressings for more 
than 24 hours) or 
• The patient dies or 
• The patient is transferred to another care setting outside the Charité Campus Virchow or is 
discharged from the hospital 
 
Adherence to the study protocol is improved using the following strategies: 
• Kick-off meetings and training on the participating ICUs and EDs 
• Subject cards at the bedside (Appendix 3) 
• Once daily follow-up visits and assessments by researchers including checks of dressing fit 
• Monthly status reports about recruitment on the participating wards 
• Unannounced patient visits by the PI for duplicate data collection and skin examination 
 
3.4 
Outcomes 
Primary outcome 
Name 
Method and metric 
Time points of 
data collection 
Pressure ulcer 
category II, III, IV, 
Unstageable, DTI 
at heels or 
sacrum 
• Clinical assessment using the NPUAP/EPUAP 2014 
PU classification system 
• Proportions developed from baseline until end of study 
(cumulative incidence) 
D0 and once daily 
 
 
 
 
 
 
 

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Secondary outcomes 
Name 
Method and metric 
Time points of 
data collection 
Pressure ulcer 
category II, III, IV, 
Unstageable, DTI 
at heels or 
sacrum 
• Clinical assessment using the NPUAP PU classification 
system 
• Proportions developed per 1000 bed days (incidence) 
D0 and once daily 
Pressure ulcer 
category I (non-
blanchable 
erythema) at 
heels and/or 
sacral area 
• Clinical assessment using the NPUAP PU classification 
system 
• Proportions developed from baseline until end of study 
(cumulative incidence) 
D0 and once daily 
Pressure ulcer 
category I (non-
blanchable 
erythema) at 
heels and/or 
sacral area 
• Clinical assessment using the NPUAP PU classification 
system 
• Proportions developed per 1000 bed days (incidence) 
D0 and once daily 
Days free of 
sacral and/or 
heels pressure 
ulcers category I, 
II, III, IV, DTI  
• Clinical assessment using the NPUAP PU classification 
system 
• Number 
D0 and once daily 
Resources 
associated with 
heel and sacral 
PU prevention 
• Preventive dressings (n), time for dressing application 
(minutes; data source: estimation) 
• Type of support surface (standard, special elastic foam, 
viscoelastic foam, low air loss overlay/mattress, 
alternating air mattress; data source: clinical records 
and direct observation) 
• Type of turning (30° degrees left/right, supine, prone, 
other; data source: clinical records) 
D0 and once daily 
Resources 
associated with 
heel and sacral 
PU treatment 
• Wound assessments (number and times; data source: 
clinical records and estimation) 
• Wound infection diagnoses, e.g. swabs, biopsies 
(number, times; data source: clinical records and 
estimation) 
• Therapeutic primary and secondary dressings 
(numbers, types), time for dressing 
application/changes (minutes; data source: clinical 
records and estimation) 
• Debridement (numbers and types incl. material; data 
source: clinical records and estimation) 
• Systemic antimicrobial treatment because of PU wound 
(number, types; data source: clinical records) 
D0 and once daily 

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Heel and sacral 
PU healing 
• Complete epithelialization 
• Mean (days) 
D0 and once daily 
 
Other variables 
Name 
Method and metric 
Time points 
Age 
• Obtained from clinical records 
• Mean (years) 
D0 
Gender  
• Obtained from clinical records 
• Proportion (male/female) 
D0 
Body mass index 
• Obtained from clinical records 
• Mean (kg/m2) 
D0 
PU risk 
• Scoring based on Charité standard 
• Risk category (none/at risk/at high risk/at very high risk) 
D0 and once daily 
PU risk 
• Scoring based on Braden score 
• Mean (A.U.) 
D0 and once daily 
Main and other 
medical 
diagnoses at 
admission 
• Obtained from clinical records 
• Coding according ICD-10  
D0 
Main and other 
medical 
diagnoses or 
procedures 
before the ICU 
stay (peripheral 
wards) 
• Obtained from clinical records 
• Coding according ICD-10 
• Coding according OPS version 2015 
 
D0 
Diabetes mellitus 
• Obtained from clinical records 
• yes/no 
D0 
Tetraplegia 
• Obtained from clinical records 
• yes/no 
D0 
Length of stay on 
peripheral wards / 
type of ward 
before ICU 
transfer 
• Obtained from clinical records 
• Mean (days)  
D0 
Length of stay in 
emergency 
department 
• Obtained from clinical records 
• Mean (hours) 
D0 

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Length of stay in 
operating room 
• Obtained from clinical records 
• Mean (hours) 
D0, or if necessary 
Length of stay in 
ICU 
• Obtained from clinical records 
• Mean (days) 
D0 and once daily 
Length of 
mechanical 
ventilation 
• Obtained from clinical records 
• Mean (hours, days) 
D0 and once daily 
Mean arterial 
blood pressure 
• Obtained from clinical records/monitoring 
• Mean (mmHg)/24h 
D0 and once daily 
Body temperature 
• Obtained from clinical records/monitoring 
• Mean (°C)/24h 
D0 and once daily 
Heart rate 
• Obtained from clinical records/monitoring 
• Mean (beats/minute) 
D0 and once daily 
Urine 
incontinence 
• Obtained from clinical records and direct observation 
• Urine in direct contact with skin 
• Mean (days) 
D0 and once daily 
Stool 
incontinence 
• Obtained from clinical records and direct observation 
• Stool in direct contact with skin 
• Mean (days) 
D0 and once daily 
Catecholamines 
• Obtained from clinical records 
• Type (adrenalin, noradrenalin ...) 
• Mean lengths of application (days) 
• Mean doses (μl/kg/min) 
D0 and once daily 
Support surface 
• Obtained from clinical records and direct observation 
• Type (standard, special elastic foam, viscoelastic foam, 
low air loss overlay/mattress, alternating air mattress) 
• Mean lengths stay on the support surface (days) 
D0 and once daily 
Positioning 
• Obtained from clinical records and direct observation 
• Type (30° degrees left/right, supine, prone, other) 
• Mean lengths of position (hours) 
D0 and once daily 
Smoker 
• Obtained from clinical records 
• Proportion (yes/no) 
D0 
 
 
 
 

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3.5 
Participant timeline 
The expected flow of participants is shown in Figure 2. The time line of an individual patient 
is shown in Table 1. 
 
Figure 2. Expected study flow chart 
 
 
 
 
 

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Table 1. Patient timeline 
 
Admission to ED 
and/or ICU 
Follow-up  
… 
End of study  
Days 
D0 
D1 
D1 + 1 
D1 + x 
In-/exclusion criteria 
X 
X 
 
 
Informed consent 
X* 
X* 
X* 
X* 
Demographics 
X 
 
 
 
Skin inspection 
X 
X 
X 
X 
Randomization 
X 
 
 
 
Application of dressings 
X 
 
 
 
Control of dressing fit/renewal 
 
 
 
 
All other clinical variables 
X 
X 
X 
X 
Ressource use (number of 
dressings, wound care 
materials) 
X 
X 
X 
X 
Adverse events monitoring and 
documentation 
 
 
 
 
*Informed consent will be sought as soon as possible after inclusion. 
 
 
3.6 
Sample size 
We are planning a study of independent cases and controls with 1 control per case.  Prior 
data of the internal quality management indicate that the average PU incidence at the ICUs 
of the Charité is 0.06 per month.  We expect that the cumulative PU incidence for 
experimental subjects will be 0.01 (RR 0.17). In order to test this hypothesis we will need to 
study 211 experimental patients and 211 control patients to be able to reject the null 
hypothesis that the PU incidence in the intervention and control groups is equal with a 
probability (power) of 0.8. The Type I error probability associated with this test of this null 
hypothesis is 0.05 (two-sided).  We will use the chi-squared test statistic to evaluate this null 
hypothesis. To prevent a possible loss of follow-up of 10%, 464 patients in total are to be 
included. This total sample size is comparable to a previous trial using a similar intervention 
and design (Santamaria et al. 2013a). The “true” PU heel and sacral PU incidence in the 
study might be higher, because we will include only “high” and “very high risk” patients. 
 

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3.7 
Recruitment 
Patients will be recruited via three different approaches: 
(1) Major trauma and/or critically ill patients admitted to the ED will be screened for in- and 
exclusion criteria at the ED. If being eligible they will be included and randomized. 
(2) Major trauma and/or critically ill internal patients who are directly admitted to the 
respective ICUs. Immediately after admission they will be screened and eventually included. 
(3) Major trauma and/or critically ill internal patients who are admitted through an in-house 
hospital transfer to the respective ICUs. Immediately after admission to the ICU they will be 
screened and eventually included. 
 
The planned study flow chart is displayed in Figure 2. 
 
It is planned to recruit patients at the: 
• Internal (CC 11 Cardiovascular Diseases) and surgical (CC 9 Traumatology and 
Reconstructive Surgery) EDs 
• ICUs 8i and 14i (CC 7 Anaesthesiology, Operating-Room Management and Intensive Care 
Medicine) 
• ICU 9i (CC 8 Surgery) 
• ICUs 43a, 43b, 47i (CC 13 Internal Medicine with Gastroenterology and Nephrology) 
All departments and wards are situated at the Campus Virchow at the Charité-
Universitätsmedizin Berlin. 
 
Practical recruitment will follow two main strategies: 
(1) Participating wards and departments contact the study nurses/research 
assistants/researchers immediately after admission of patient potentially meeting the 
inclusion criteria between 7:00 and 19:00 (Monday to Sunday). In that case the study 
personnel will immediately approach the patient and performs the screening. If eligible, the 
patient is included, randomized and the intervention (in the intervention group only) is 
applied. 
(2) Study personnel will do walk rounds and visits on all participating wards and department 
between 7:00 and 19:00. Because patients will be included within 6 hours after admission to 
the respective ICUs, it is possible to cover a recruitment time per day from approximately 
1:00 to 19:00 (18 hours). If eligible patients are detected, screening is conducted and the 
patients are potentially included. 
Based on the number of departments and wards and the corresponding cases per months 
according to the hospital statistics it is assumed, that enough patients can be recruited within 
the given time frames. 

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4 
Methods: assignment of interventions 
 
4.1 
Assignment of interventions 
A simple randomisation with a 1:1 allocation as per computer generated randomisation table 
will be used. The randomisation table will be created at the Department of Biometry and 
Clinical Epidemiology independently from the CRC. 
 
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. At the morning of the 
daily recruitment times from 7:00 to 19:00 approximately 5 to 8 consecutive envelopes are 
taken and potentially used during the day. If screening reveals eligibility for the trial, the next 
numbered envelope will be opened by the study personnel and the patient is assigned.  
 
4.4 
Blinding 
Due to the nature of the intervention caregivers (e.g. nurses, doctors) and study 
assistants/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 data collectors will be trained in obtaining accurately the variables of interest (see 4.4). 
The six category PU classification system endorsed by the NPUAP/EPUAP (2014) will be 
used. The interrater agreement will be tested prior and during the trial using PUCLAS3 
(Beeckman, Schonhoven 2014). 
 
Paper source data (SD) and paper case report forms (CRFs) will be used to document all 
study variables of interest. All available routine patient documentation will be used as SD. 
This information will be obtained either from paper or electronic charts. SD collected explicitly 
for the study in addition to the routine documentation will be (based on 4.4): 
• PU categories at heels and sacrum 
• Resources associated with heel and sacral PU prevention and treatment 
• Heel and sacral PU healing times 
• Braden score 
• Support surface 
• Positioning 
 
After SD verification via external monitoring (approximately 10%) pCRFs will be transmitted 
to the data manager. The data manager creates an SPSS file and data of the pCRFs 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. A 
summary of the data collection and management process is shown in Figure 3. 
 
 
 
 

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Figure 3. Data collection and management 
 
 
 
 
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). Baseline 
demographic (age, gender, PU risk etc.) and clinical characteristics (e.g. medical diagnoses, 
duration of ventilation) of each group will be displayed in a table. 
 
The primary end point PU incidence category II, III, IV, DTI at heels and/or sacrum will be 
compared using a Chi-squared test. This will be the main analysis of this primary outcome. A 
logistic regression will be applied to adjust for baseline covariates. An alpha level of 5% (two-
sided) will be applied. Kaplan-Meier analyses and logrank test will be used to compare the 
times to development of a new PU between groups. Multiple Cox regression analysis will be 
performed to adjust for potential confounders. Data will be analysed as intention to treat. 
 

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Secondary outcomes will be analysed in a similar way. Depending on the level of 
measurement (nominal, ordinal, continuous) secondary outcomes will be described using 
absolute and relative frequencies or arithmetic means, medians and spread parameters 
(minimum, maximum, interquartile ranges, SDs). Chi-squared or t-tests will be applied to 
compare groups. In case of normality assumption being violated, the Mann-Whitney U test 
will be used instead of t-test. 
 
For daily measurements, missing values will be imputed via LOCF method, and the results 
will be compared to those without imputation. 
 
A cost effectiveness analysis (CEA) comparing both groups will be conducted. Quantities of 
used preventive dressings including labor costs for application in the intervention group and 
quantities of used PU treatment materials (e.g. dressings, time) will be documented. Current 
market prizes in Euro will be used to calculate the total costs per group. An incremental cost 
effectiveness ratio (ICER) will be calculated by dividing the mean differences in costs by the 
mean differences in effects. In order to make results comparable a similar approach like the 
work by Santamaria et al. 2013b will be used. 
 
All analytic steps including the CEA will be repeated for the two subgroups heel PUs and 
sacral PUs. 
 

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6 
Methods: monitoring 
 
6.1 
Data monitoring 
A formal data monitoring committee will not be implemented. 
 
6.2 
Interim analysis 
One interim analysis will be done after 50% of the sample (n = 232) have completed the 
study. The study will be stopped when there appears to be a negligible chance of 
demonstrating superiority if enrolment is fully completed. After the interim analysis the study 
will be stopped, if the conditional power (CP) based on the observed data after 50% of 
recruitment is less than 60% to reject the null hypothesis, that incidences in both arms are 
equal (Lachin 2005). 
 
 
6.3 
Harms 
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 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 

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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 
iii. 
led to foetal distress, foetal death or a congenital abnormality or birth defect. 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
 
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 5. 
 
6.4 
Auditing 
The trial conduct is audited by an external monitor. The following processes will be reviewed: 
• Patient enrolment/patient existence 
• Consent 
• Eligibility 
• Allocation 
 
 
 

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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 a medical device 
class 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 
applying silicone dressings at heels and the sacral skin to prevent skin ulcerations have not 
been reported so far (Santamaria et al. 2013a, Clark et al. 2014). Based on existing evidence 
it is highly probable that the intervention has positive effects in maintaining skin and tissue 
integrity. This is also one reason, why the use of preventive dressings is considered as one 
of new PU prevention strategies in the latest PU prevention and treatment guideline 
(NPUAP, EPUAP, PPPIA 2014). Potential benefits clearly outweigh possible risks and 
therefore this study inclusion is justified. 
 
7.2 
Protocol amendments 
The ethics committee will be informed about possible study amendments. 
 
7.3 
Consent 
PU risk is highest during the first days of hospital admission. Critically ill and ICU patients are 
at especially high risk. Therefore it is important to start preventive interventions immediately 
after admission to the ED or to the ICU (within 6 hours). Patients meeting the inclusion 
criteria and who are able 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. Patients being unconscious, ventilated, confused or are unable to give informed 
consent but meeting the inclusion criteria will be also included immediately. In that case 
informed consent from the legal representatives will be obtained as soon as possible. 
Individual consent will be sought in addition when patients subsequently regain capacity. If 
patients or legal representatives decide not to participate, all study data obtained so far are 

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deleted, the intervention will be stopped and PU preventive care procedures will be 
continued as usual. Any study participants or legal representatives can withdraw his or 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 CRC. 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. An additional copy of 
the file is archived on CD-ROM together with the TMF and source data by the Charité. 
 
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 PI and therefore has full access. 
 
7.7 
Ancillary and post-trial care 
Ancillary and/or post-trial care is not planed. All PU preventive and therapeutic interventions 
follow the clinical algorithms of the Charité-Universitätsmedizin Berlin. Trial participation will 
not lead to additional care. 
 
7.8 
Dissemination policy 
A clinical study report will be prepared according to the ICH E3 guideline. Results will be also 
made available at the trial register clinicaltrial.gov. The study results will be presented in an 
international scientific journal following the guidance of the CONSORT 2010 statement 
(Schulz et al. 2010) and in at least one German speaking journal. Any publication will take 
account of the ‘Uniform requirements for manuscripts submitted to biomedical journals’. 
 

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Results will be presented as posters and orally at international conferences (e.g. the Annual 
Meeting of the European Pressure Ulcer Advisory Panel, EWMA conference) and at national 
German speaking conferences (e.g. Bremer Wundkongress, Jahrestagung des Deutschen 
Netzwerks Evidenzbasierte Medizin, Dreiländer-Kongress für Pflege und 
Pflegewissenschaft). 
 
 
 
 
 

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8 
References 
Institute for Applied Quality Improvement and Research in Health Care GmbH (AQUA). 
German Hospital Quality Report 2012. Göttingen. 
Beeckman D., Schoonhoven L., European Pressure Ulcer Advisory Panel. PuClas3 
eLearning Module. University Centre for Nursing & Midwifery and European Pressure 
Ulcer Advisory Panel. 2014. 
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, 
Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. 
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. 
BMJ. 2013;346:e7586. 
Charité-Universitätsmedizin Berlin. Verfahrensregelung Dekubitusprophylaxe. 2012. 
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. 
European Commission. Guidelines on medical devices. Clinical investigations: serious 
adverse event reporting. 2010. http://ec.europa.eu/health/medical-
devices/files/meddev/2_7_3_en.pdf 
Hay RJ, Johns NE, Williams HC, Bolliger IW, Dellavalle RP, Margolis DJ, Marks R, Naldi L, 
Weinstock MA, Wulf SK, Michaud C, J L Murray C, Naghavi M. The global burden of 
skin disease in 2010: an analysis of the prevalence and impact of skin conditions. J 
Invest Dermatol. 2014;134(6):1527-34. 
Kottner J, Lahmann N. [Comparative quality measurements part 3: funnel plots]. Pflege. 
2014;27(1):41-9. 
Kottner J, Raeder, K. Assessment and Documentation of Pressure Ulcers. In D.R. Thomas, 
G. Compton (eds.), Pressure Ulcers in the Aging Population: A Guide for Clinicians 
(p. 47-65). New York: Springer 2014. 
Lachin LM. A review of methods for futility stopping based on conditional power. Stat Med 
2005;24(18):2747-64 
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. 
Park KH. The effect of a silicone border foam dressing for prevention of pressure ulcers and 
incontinence-associated dermatitis in intensive care unit patients. J Wound Ostomy 
Continence Nurs. 2014;41(5):424-9. 
Santamaria N, Gerdtz M, Sage S, McCann J, Freeman A, Vassiliou T, De Vincentis S, Ng 
AW, Manias E, Liu W, 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. 
2013a May 27. doi: 10.1111/iwj.12101. 
Santamaria N, Liu W, Gerdtz M, Sage S, McCann J, Freeman A, Vassiliou T, Devincentis S, 
Ng AW, Manias E, Knott J, Liew D. The cost-benefit of using soft silicone multilayered 
foam dressings to prevent sacral and heel pressure ulcers in trauma and critically ill 
patients: a within-trial analysis of the Border Trial. Int Wound J. 2013b Oct 6. doi: 
10.1111/iwj.12160. 
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. 
Unbeck M, Sterner E, Elg M, Fossum B, Thor J, Pukk Härenstam K. Design, application and 
impact of quality improvement 'theme months' in orthopaedic nursing: a mixed 
method case study on pressure ulcer prevention. Int J Nurs Stud. 2013;50(4):527-35. 
 
 
 

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9 Appendices 
 
 
 

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Appendix 1: Standard operating procedure to apply Mepilex® 
Border Sacrum on intact skin 
 
Deutsch 
English 
Inhaltsverzeichnis 
 
1. Beschreibung des Produkts 
2. Vorbereitungen 
3. Arbeitsschritte 
4. Besondere Anweisungen 
5. Mögliche Fehler/Störungen/Problem-
Lösungen 
6. Lagerbedingungen / Reinigung 
Table of Contents 
 
1. Description of Device  
2. Preparation  
3. Workflow 
4. Special Instructions 
5. Possible Error/Disruptions/Problem 
Solutions 
6. Storage Conditions/Cleaning 
1. Beschreibung des Produkts 
Mepilex® Border Sacrum ist ein Schaumverband 
zur Prävention und Behandlung von Dekubitus 
im Sakralbereich. Er ist weich, anpassungsfähig 
und wasserfest. Der Verbandswechsel erfolgt 
nahezu schmerzfrei und atraumatisch. Es 
verbleiben keine Rückstände auf der Haut.  
Der Verband wird alle 3Tage gewechselt.  
1. Description of Device/Hardware 
Mepilex® Border Sacrum is a special foam 
dressing for prevention of sacral pressure ulcer. 
It is very smooth, flexible/adaptable and water-
resistant. Changing is nearly painless and non-
traumatic.  
 
Remove and replace dressing after 3 days. 
 
Lieferumfang zum Produkt: / Delivery contents of the device: 
Mölnlycke Health Care 
Mepiplex® Border Sacrum 
 
18x18 cm Product code: 282000 
 
23x23 cm Product code: 282400 
2. Vorbereitungen  
Bestimmte Standards sollen vor und während 
der Applikation eingehalten werden. 
a) Vorbereitung des Arbeitsplatzes: 
 
Legen Sie sich zwei Schaumverbände 
bereit, 
 
Ziehen Sie sich Handschuhe an, 
 
Legen Sie sich bei Bedarf 
Waschlappen und Handtuch für die 
optimale Reinigung des 
Wundauflagegebietes bereit. 
b) Lagern Sie den Patienten bequem auf eine 
Seite, holen Sie bei Bedarf eine zweite 
Pflegekraft oder Lagerungsmittel zur 
Unterstützung. 
c) Stellen Sie sich einen Abwurfbehälter bereit.  
2. Preparation 
A set of standards should be maintained before 
and during application. 
a) Prepare a place/table with all material: 
 
Prepare two dressings, 
 
Put on gloves, 
 
For cleaning the wound area provide 
washcloth and towel (only if necessary) 
b) Place the patient on one site (support with 
pillows) maybe you need help of another 
colleague. 
c) Prepare a dustbin. 
 
 
 

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3. Arbeitsschritte 
a) Inspektion des Areals. Beurteilung der 
Anatomie des Patienten und Entscheidung 
welche Applikationsform in Bezug auf 
Lagerung und ggf. Einschränkungen (z.B. 
Inkontinenz) für den Patienten in Frage 
kommt. (Variante A oder B in Schritt e). 
3. Workflow 
a) Area to protect. Assess the patient’s 
anatomy and evaluate if the dressing should 
be placed according to Figure A or B based 
on coverage and/or potential issues with 
incontinence.  
 
 
b) Stellen Sie sicher, dass die Haut frei von 
Dimethicone, Schutzfilmen und Salben ist. 
Entfernen Sie die Mitteltrennfolie des 
Verbandes. Das vorherige applizieren von 
Hautschutzprodukten ist nicht notwendig. 
b) Ensure the skin is dry and free of 
dimethicone, skin sealants, emollients and 
remove the central release film. Use of skin 
barrier under dressing is not necessary. 
 
 
c) Mit Hilfe eines Kollegen applizieren Sie den 
Wundverband in den Sakralbereich und der 
Analfalte, indem eine Gesäßhälfte leicht 
nach oben gezogen wird. 
c) With assistance from a colleague, hold 
buttock apart. Apply dressing to sacral area 
and into upper aspect of gluteal cleft. 
 
d) Ziehen Sie nacheinander die seitlichen 
Schutzfolien langsam ab und streichen Sie 
den Schaumverband nach außen hin aus. 
Überprüfen Sie, ob der Verband richtig 
positioniert ist sowie faltenfrei und fest an 
der Haut haftet.  
d) Run side of hand along gluteal cleft to 
ensure secure placement. Gently smooth 
each side into place. 
 
 
 
 
 
 

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e) Variante A – Produktapplikation/ Figure A - Product placement. 
 
 
 
e) Variante B – Produktapplikation/ Figure B - Product placement inverted. 
 
 
f) 
Lagern Sie den Patienten in seitlicher 
Position oder auf den Rücken. 
f) 
Remove the patient in a site or back position 
 
4. Besondere Hinweise  
a) Tägliche Überprüfung des Verbandes und 
Dokumentationsführung. 
b) Achten Sie darauf, dass die Verbandränder 
bei Entfernung oder Erneuerung des 
Schaumverbandes faltenfrei, glatt und fest 
kleben. 
c) Der Verbandwechsel erfolgt alle 3 Tage und 
so lang der Patient einem Risiko ausgesetzt 
ist. 
 
4. Special Instructions 
a) Daily assessment of the dressing and 
documentation. 
b) Removal and reapplication of dressing. 
Ensure the border of the dressing is 
smooth/even with no wrinkles. 
c) Remove and replace dressing after 3 days 
as long as the patient is still at risk. 
5. Mögliche Störungen / Problemlösungen 
a) Die Auflagefläche muss trocken und frei von 
Pflegeprodukten und eventuellen 
Pflasterresten sein, damit der 
Schaumverband gut auf der Haut haftet. 
b) Keine zusätzlichen Pflegeprodukte 
verwenden. 
5. Possible Error / Problem Solutions 
a) The application area must be dry and free of 
dimethicone, skin sealants, emollients and 
remove the center release film for good 
adhesion. 
b) Don’t use any other additional products. 
6. Lagerung und Reinigung 
a) Gestalten Sie Ihren Arbeitsplatz 
übersichtlich und sauber.  
b) Lagern Sie die Wundverbände (Mepiplex® 
Border Sacrum) trocken und  bei 
Raumtemperatur. 
6. Storage Conditions/Cleaning 
 
Clean and tidy up your workplace 
 
Store the dressings Mepiplex® Border 
Sacrum at room temperature in a dry place. 
  
 
 
 

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Appendix 2: Standard operating procedure to apply Mepilex® 
Border Heel on intact skin 
 
Deutsch 
English 
Inhaltsverzeichnis 
 
1. Beschreibung des Produkts 
2. Vorbereitungen 
3. Arbeitsschritte 
4. Besondere Anweisungen 
5. Mögliche Fehler/Störungen/Problem-
Lösungen 
6. Lagerbedingungen / Reinigung 
Table of Contents 
 
1. Description of Device  
2. Preparation  
3. Workflow 
4. Special Instructions 
5. Possible Error/Disruptions/Problem 
Solutions 
6. Storage Conditions/Cleaning 
 
1. Beschreibung des Produkts 
Mepilex® Border Heel ist ein speziell an die 
Fersenform angepasster Schaumverband. Er ist 
weich, gut anpassungsfähig und wasserfest. Der 
Verbandswechsel erfolgt nahezu schmerzfrei 
und atraumatisch. Der Schaumverband  ist 
selbsthaftend. Eine sekundäre Fixierung ist nicht 
erforderlich, sodass keine Rückstände auf der 
Haut verbleiben.  
Der Verband wird alle 3 Tage gewechselt. 
 
1. Description of Device 
Mepilex® Border Heel it is a special foam 
dressing for prevention of heel area pressure 
ulcer. It is very smooth and flexible/adaptable 
and water-resistant. Changing is nearly 
painless and non-traumatic. 
 
Remove and replace dressing after 3 days. 
 
 
Lieferumfang zum Produkt: /  
Mölnlycke Health Care 
Mepiplex® Border Heel  
 
18,5cm x 24cm 
Delivery contents of the device: 
 
2. Vorbereitungen  
Bestimmte Standards sollen vor und während 
der Applikation eingehalten werden. 
 
a) Vorbereitung des Arbeitsplatzes: 
 
Legen Sie sich zwei Schaumverbände 
bereit, 
 
Ziehen Sie sich Handschuhe an, 
 
Legen Sie sich bei Bedarf 
Waschlappen und Handtuch für die 
optimale Reinigung des 
Wundauflagegebietes bereit.  
b) Lagern Sie den Patienten/Probanden 
bequem  auf eine Seite, holen Sie bei 
Bedarf eine zweite Pflegekraft oder 
Lagerungsmittel zur Unterstützung. 
2. Preparation of measurement 
A set of standards should be maintained before 
and during the application. 
 
a) Prepare a place/table with all material: 
 
Prepare two dressings,  
 
Put on gloves, 
 
For cleaning the wound area provide 
washcloth and towel (only if 
necessary). 
b) Place the patient on one site (support with 
pillows) maybe you need help of another 
colleague. 
c) Prepare a dustbin. 
 
 

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c) Stellen Sie sich einen Abwurfbehälter bereit. 
 
 
3. Arbeitsschritte 
a) Inspektion der Ferse, entfernen Sie die 
Mitteltrennfolie. Säubern Sie bei Bedarf das 
Wundauflagengebiet, achten Sie darauf, 
dass die Haut trocken ist. 
3. Workflow 
a) Remove the central release film. Assess 
application area (heel area). 
 
 
 
b) Legen Sie den Schaumverband auf das 
Fersengebiet und entfernen Sie die 
Schutzfolie (markiert mit „B“). 
b) Apply the adherent part of the dressing 
marked “B” in the instructions for use 
illustration under the foot. Do not stretch. 
 
 
 
c) Entfernen Sie nacheinander die Folie von 
den Seitenflügeln des Verbandes und 
fixieren ihn faltenfrei. Verband nicht 
auseinander ziehen! 
c) Remove the side flap protection film. Apply 
and smooth side-flap. Repeat with the 
other side. Do not stretch. 
 
 
  
 
d) Ziehen Sie die restliche Schutzfolie auf 
beiden Seiten des Verbandes ab (markiert 
mit „A“) und fixieren ihn, wie auf der 
Abbildung dargestellt, unterhalb der 
Achillessehne. Verband nicht auseinander 
ziehen! 
d) Apply the adherent part of the dressing 
marked A on the instructions for use 
illustration on the Achilles’ tendon. Remove 
the upper protection films on each side, 
apply, and smooth the dressing. Do not 
stretch. 
 
 
.
 
e) Lagern Sie den Patienten in seitlicher 
Position oder auf den Rücken. 
e) Remove the patient in a site or back 
position. 

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4. Besondere Hinweise  
a) Tägliche Überprüfung des Verbandes und 
Dokumentationsführung. 
b) Achten Sie darauf, dass die Verbandränder 
bei Entfernung oder Erneuerung des 
Schaumverbandes faltenfrei, glatt und fest 
kleben. 
c) Der Verbandwechsel erfolgt alle 3 Tage 
anhand des Wund-Assessments und 
so lang der Patient einem Risiko ausgesetzt 
ist. 
4. Special Instructions 
a) Daily assessment of the dressing and 
documentation. 
b) Removal and reapplication of dressing. 
Ensure the border of the dressing is 
smooth/even with no wrinkles. 
c) Remove and replace dressing after 3 days 
as long as the patient is still at risk, replace 
dressing according to schedule on the 
Wound Assessment Form documentation. 
 
5. Mögliche Störungen / Problemlösungen 
a) Die Auflagefläche muss trocken und frei von 
Pflegeprodukten und eventuellen 
Pflasterresten sein, damit der 
Schaumverband gut auf der Haut haftet. 
b) Keine zusätzlichen Pflegeprodukte 
verwenden. 
5. Possible Error Messages/ Disruptions/ 
Problem Solutions 
a) The application area must be dry and free 
of dimethicone, skin sealants, emollients 
and remove the center release film for 
good adhesion. 
b) Don’t use any other additional products. 
 
6. Lagerung und Reinigung 
 
a) Gestalten Sie Ihren Arbeitsplatz 
übersichtlich und sauber.  
b) Lagern Sie die Wundverbände (Mepiplex® 
Border Heel) trocken und  bei 
Raumtemperatur. 
6. Storage Conditions/Cleaning 
a) Clean and tidy up your workplace 
b) Store the dressings Mepiplex® Border 
Heel at room temperature in a dry place. 
  
 
 
 
 

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Appendix 3: Patient card 
 
 
 

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Appendix 4: NPUAP/EPUAP pressure ulcer classification 2014 
 
  
 

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Appendix 5: SAE Reporting form