Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial
Phase: NA
Conditions: Pressure Ulcer Risk
Sponsor: Istituto Ortopedico Rizzoli

 
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EFFICACY OF THE USE OF A POLYURETHANE FOAM 
MULTILAYER DRESSING IN THE SACRAL AREA, IN 
ADDITION TO STANDARD HEALTHCARE, TO PREVENT THE 
ONSET OF PRESSURE ULCER IN PATIENTS AT RISK. 
MULTICENTRIC RANDOMIZED  CONTROLLED TRIAL.  
 
 
ID: MULTISCHIUME 
 
Funding 
The dressing was supplied free of charge for all the patients in the study by Coloplast on the 
understanding that they only provided the dressings and signed an agreement to supply the 
free samples without influencing the methods and elaboration of the data collected in any 
without influencing the methods and elaboration of the data collected in any way and had no 
role in data analyses or report writing. 
 
Conflicts of interests 
The authors declared no potential conflicts of interest with respect to the authorship and/or 
publication of this protocol. 
 
Background 
Pressure injuries (PD) represent one of the complications most closely related to the care of 
the bedridden patient. In literature, their incidence can range from 7% to 71.6% (Moore & 
Cowman, 2014), particularly in surgical patients (Gardiner, Reed, Bonner, Haggerty, & Hale, 
2016). Orthopedic patients have a higher risk of developing pressure sores in this population: 
one study reports an incidence of such injuries of 11.9-19.2%, compared to an incidence of 
8.8-9, 2% in surgical patients in general (Al-Shadedi, 2012). In the medical field, a recent 
Italian study has been found that indicates an incidence of LdP of 6.5% (Palese 2017) while in 
intensive care it stands at 13.1% (Santamaria 2015). 
PDs are often difficult to heal, painful and have a negative impact on the patient's quality of 
life up to the risk of mortality (Jaul 2015 A; Jaul 2015 B). Interventions aimed at their 
prevention play an important role both in increasing the quality of care and in reducing health 

 
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expenditure as well as in ensuring a better quality of life for the patient (Bernabei 2011; 
NPUAP 2014). PDs can be prevented through risk assessment, skin inspection, nutrition and 
hydration balance and through the use of devices that distribute pressure. Strategies to 
increase patient mobility also contribute substantially to injury prevention (NPUAP 2014). 
Lastly, advanced dressings of different shapes and materials could help reduce pressure, 
friction, skin stretching and effectively manage the humidity level. (Santamaria 2015). 
The rationale for the use in prevention of products useful for the treatment of pressure injuries 
is also described in the 2013 systematic review (Moore 2013). The incidence of PD is 
probably reduced through the ability of foam dressings to redistribute mechanical forces. The 
Guidelines of the European and United States National Pressure Ulcer Advisory Panels 
(EPUAP and NPUAP) also suggest that the use of foam dressings may protect parts of the 
body at risk of stretch injuries. The market offers different types of advanced dressings 
compared to the material they are made of (hydrocolloids, polyurethane foams), their 
thickness (single or multi-layer) and their dimensions. 
Various in vitro comparative studies are available where the different abilities of the main 
brands of dressings are compared with the pressure redistribution (Call 2015; Matsuzaki 
2015; Miller 2015), liquid management (Young 2007) and shear forces (Levy 20015 and 
Levy 20016) which are the main causative factors of PD development (NPUAP 2014). In 
these in vitro studies the material that seems to be most effective is polyurethane foam 
(Matsuzaki 2015; Miller 2015), especially multilayer (Black 2015). 
Two systematic reviews published in 2013 and 2014 then evaluated the efficacy on patients of 
using advanced multi-layer polyurethane dressings in prevention to reduce the incidence of 
pressure injuries (Clark 2014; Moore 2013). The results of both systematic reviews, although 
in favor of the use of dressings, are considered by the authors to be inconclusive due to the 
weakness of the study design found and therefore the high risk of bias. Both reviews 
concluded by soliciting the production of methodologically more rigorous clinical studies 
(Clark 2014; Moore 2013). Recently, some trials have been published which confirm the 
preventive efficacy of polyurethane multilayer foams (Santamaria 2015; Kalowes 2016; Forni 
2018; Santamaria 2018) but the populations investigated are very specific, limiting the 
generalizability of results. 
AIM 

 
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The aim of the present study was to assess whether the application of a multilayered dressing 
made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to 
standard preventive care reduces the rate of pressure ulcer (PU) and their severity in 
population at risck admitted in acute care Hospital.  
 
Study endpoint 
Primary Endpoint 
Incidence of PD to the sacrum of any category detected during the first 7 days of 
hospitalization. 
The 7-day cut off derives from the data in the literature with respect to the average times of 
onset of the lesions (4th day in the medical field, 5 ° in the surgical field and 3 ° in the 
intensive care unit) with standard deviations that allow to affirm that after 7 days in the acute 
patients the PD event is extremely rare (Palese 2017; Chiari 2017; Santamaria 2015). PD is 
defined as a damage to the skin and underlying tissues due to pressure, stretching or friction 
or a combination of these factors (NPUAP 2014). The incidence of PD is represented by the 
PD who develop during hospitalization and are not present when the patient is admitted. The 
injuries will be classified according to the classification defined by the guideline prepared by 
NPUAP 2014. (attachment). 
 
Secondary Endpoints: 
• Incidence of PD to the sacrum category ≥ II ° according to the NPUAP scale 
• Skin irritation / damage due to adhesive dressing 
• Day of onset of the PD 
• Number of dressings used 
• Number of patients who stop treatment due to discomfort caused by the dressing 
(withdrawal) 
 
 
Other study variables / data collected 
- Gender 
- Age 

 
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- Origin of the patient: first aid, another ward or facility, Short Observation (OBI), Home 
- Pregressed (healed) PD to the sacred  
- Patient risk level measured with the Braden scale (Pancorbo-Hidalgo PL 2006) 
- Days in the study 
- Use of the diaper 
- Use of the bladder catheter 
- Use of anti-decubitus surface (static, preventive dynamics, curative dynamics and air 
release) 
- Daily presence of the caregiver (presence at least during a meal, never, always) 
 
Study Population  
Inclusion Criteria: 
• Patients at risk of developing PD measured with the Braden scale (Braden ≤ 16) with intact 
sacral skin and / or with signs of healing from previous sacral lesions. 
• Patients or legal guardians who consent to the study 
• Adult patients 
. Male and female gender 
• Expected hospital stay and / or life expectancy > 72 hours 
• Patients hospitalized for no more than 24 hours 
 
Exclusion criteria: 
• Patients with known allergy to the products under study or with dermatological pathologies 
that prevent the use of topical products 
• Patient with, upon entering the ward, advanced preventive dressing in the sacral region 
Design 
Trial randomizzato e controllato di superiorità in cieco (elaborazione dati) a gruppi paralleli 
con rapporto di allocazione di 1:1 con randomizzazione a blocchi di 10 e bilanciati per reparto 
e per area. Non è possibile la cecità degli outcome assesor in quanto nei pazienti del gruppo 
sperimentale resta spesso una traccia cutanea della presenza della schiuma (impronta 
cutanea). 

 
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Randomized controlled superiority trial (blinded only data processing) with parallel groups. 
Allocation ratio of 1: 1 with randomization in blocks of 10 and balanced by department and 
by area. The blindness of outcomes assesor is not possible as in the patients of the 
experimental group there is often a cutaneous trace of the presence of the foam (skin 
impression). 
 
Materials and methods 
 
Areas involved 
Surgical Area: general or specialist surgery departments. 
Medical Area: geriatrics or neurology or internal medicine departments. 
Intensive Area: intensive care or intensive care units. 
For each area of each participating center a sample of 40 subjects is expected, randomization 
will be done by areas. 
Intervention: 
Application of MSP in the sacral region within 24 hours of admission and replaced when it 
comes off, gets wet or gets dirty in addition to standard preventive care (see below). 
MSP is a multilayer foam consisting of: a multi-layered dressing consisting of a polyurethane 
foam and a super-absorbent hydrocapillary pad, two layers of polyurethane film, one external 
and one internal, and a pressure-sensitive adhesive (PSA) that holds together the two 
absorbent layers. The last layer, in contact with the lesion and the skin, is in delicate adhesive 
silicone, non-adherent, perforated. 
The foam must be raised to the margins at least once a day to check the condition of the 
underlying skin. If on the seventh day after randomization the patient is still hospitalized, 
after the inspection of the skin, the data collection form (CRF) is closed and the study 
concluded. 
The medication will be provided free of charge for all the subjects in the studio by the 
manufacturer. The company will only supply the dressings. A written agreement was signed 
in which the company agrees to provide free samples of the product being studied without 

 
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affecting in any way the methodology of drafting the protocol, conducting the study, 
analyzing the data and publishing the results. 
 
Comparison: 
Standard preventive care. If on the seventh day after randomization the patient is still 
hospitalized, after the inspection of the skin, the CRF is closed and the study concluded. 
Standard preventive care 
Evaluation of the risk of developingPD with a Braden scale within 24 hours of admission. 
Positioning of the patient on a preventive or curative anti-decubitus mattress (static or 
alternating pressure) if Braden value ≤ 16 or in any case according to the hospital policy, 
daily inspection of the skin and mobilization of the patient at least every 4 hours (in the 
surgical patient at least in the post-operative period) if the clinical conditions allow it 
(NPUAP 2014). Management of incontinence, humidity control and prevention of skin 
maceration and rubbing / friction during postural changes as per hospital policy. 
 
Method 
At the entrance of the patient in the ward, the nurse dedicated to the first reception assesses 
whether the person has the necessary criteria to be enrolled in the study. In the positive case, 
he/she will explain to the patient or to his legal guardian, the rationale of the study, he/she 
will submit the information requesting consent to the participation granting the necessary time 
for reading and consultation before any consent and signature. If the patient consents, the 
nurse has the consent signed and attached to the medical record by setting the first part of the 
CRF (attachment). If the patient at risk refuses the participation, if he/she  has other exclusion 
criteria or if it is not possible to collect the consent, the nurse transcribes it on the CRF and 
files it. If the patient agrees to participate in the study, the dedicated nurse proceeds to 
randomization (see below for methods) taking the first opaque envelope according to the 
external progressive number. It transcribes in the CRF the date, the patient's ID, if he already 
has PD not to the sacrum and their category and location. It also sign the study arm and other 
variables of interest. If the patient is in the experimental arm, the nurse, in addition to the 
standard preventive care, applies the MSP to the sacrum and writes date and time on the CRF 
and on the MPS. However, the foam must be applied within 24 hours of admission. If this 

 
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time interval is exceeded, the researcher will mark the problem in CRF in the "NOTES" part 
and the patient leaves the study and the CRF is archived. 
• Operating room: when the patient is eventually taken to the operating room to undergo 
surgery, the operating room nurse checks if the patient at risk is enrolled in the study. At the 
end of the surgical intervention, when returning to the ward, if the patient belongs to the MSP 
arm, check if the foam has been removed (surgery often necessary to proceed with the 
preparation of the sterile field for spinal anesthesia and for the procedure surgery) and 
repositions it. 
• If the patient is transferred to the intensive care unit at any time during his or her treatment, 
the dedicated nurse will also enclose the data collection form with the documentation, which 
will continue to be filled in according to the protocol written by the dedicated intensive care 
nurse . 
• If the patient leaves the operating room directly for intensive care, it is the duty of the 
dedicated nurse in the ward to send the CRF to the intensive care unit to continue the study, if 
it is not already attached (see previous paragraph). The Intensive care nurse will collect data 
with the same methods and timing. 
• If the patient is transferred to a ward not involved in the study, the CRF is completed and the 
enrollment is closed (as if he were discharged). 
 
Daily data collection 
Every morning the data collection nurse: 
• Assess the patient's skin (shoulder, sacrum, elbows, heels, back, calves, thighs, ankles…) 
and completed the daily CRF part; 
• If the patient belongs to the intervention arm (MSP), the nurse will also check daily whether 
the dressing is still tight, dry and clean. If the dressing is detached even partially the MSP is 
replaced (do not put reinforcement patches) and the change is reported in the CRF. 
• Every day (once a day) in patients with MSP, it removes an edge to check if the skin of the 
sacrum is still intact, marking the result of the inspection in the CRF. 

 
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• If it replaces the MSP (dirty, detached or wet) it marks it in the CRF and writes the date and 
time on the MPS itself. The foam will however be removed upon discharge regardless of the 
day of admission and in any case no more than 7 days (as per the indication of maximum 
permanence of the MSP provided by the manufacturer). 
• Upon return of the patient from the operating room, the referring nurse verifies, as soon as 
possible, that the patient of the intervention arm still has the polyurethane foam in the sacrum. 
Otherwise apply it by marking it in the CRF. 
• At discharge or on the appearance of pressure lesion on the sacrum ≥ 2nd category, the CRF 
is closed and the patient ends the study. If the patient has developed PD the treatment of the 
lesion will be performed according to the hospital policy. 
• The medication will be removed, however, no later than the first 7 days of admission after 
which the patient ends the study. 
 Study exit criteria 
- Withdrawal of informed consent before randomization 
- Not randomized within 24 hours of admission 
 
Conclusion of the study in the single recruited subject 
 
• Withdrawal of consent after randomization 
• The appearance of irritation to the skin caused by the dressing. The dressing is removed, 
reported in CRF and irritation treated as per hospital policy. 
• At the request of the patient due to discomfort due to preventive medication. 
• On discharge / death / transfer to ward not involved in the study before the 7th day after 
randomization 
• After 7 days from randomization in the absence of PD to the sacrum 
• The appearance of pressure injury to the sacrum higher than the first category 
 
Sample size 

 
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From a randomized monocentric study of at-risk patients with a hip fracture where 
polyurethane foams were used in prevention, the incidence in the experimental group was 
4.5% while in the control group of 15.4%. Similar deltas had also been identified in other 
trials in intensive care patients. Assuming similar results in the population subject of the 
present study and taking into account an alpha error of 0.05 and a beta error of 20%, it is 
necessary to enroll at least 228 patients at risk. In order to allow analyzes by subgroup (see 
the "statistical analysis" section) the sample size must be guaranteed for each area (medical, 
surgical, intensive). 
Taking into account also a possible loss at the follow-up of 10% and also assuming a 10% 
withdrawal rate, the necessary sample will be 280 patients per area and therefore a total of 
840 patients (420 per arm) . Each hospital involved will enroll 40 patients per area involved in 
that specific hospital.  
Randomization  
At the Research Center for Health Professions of the Rizzoli Orthopedic Institute in Bologna 
(coordinating center), using the site: www.randomization.com, a randomization list will be 
generated in blocks of 10. A sequence of opaque envelopes will be prepared with outside a 
progressive number. Inside the envelope a label will be placed that will contain the words 
"yes" or "no", according to the sequence indicated by the generated list. 
The envelopes will always be sealed at the Research Center and the list kept under lock and 
key. The envelopes will be placed in a dedicated box and delivered to the nursing  research 
manager of the hospitals involved in the study. In each ward/area a reference nurse will be 
identified and 40 envelopes delivered. 
 
Statistical analysis 
The analysis of the results will be carried out for Intention to Treat. 
All continuous data will be expressed in terms of average and standard deviation. One Way 
ANOVA will be used to evaluate the differences between the averages of the experimental 
and comparison group. If the Levene test for homogeneity of variance were significant (p 
<0.05), the Mann Whitney test will be used. For all dichotomous variables the incidence, 
relative risk, relative risk reduction and number needed to treat will be calculated. The exact 

 
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Fisher test will be used to evaluate the differences between the incidences of different 
outcomes between the experimental group and the control group. 
Subgroup analysis: 
• by area of belonging (medical, surgical or intensive) 
• by risk level according to the Braden classification: Severe (total score 9); High Risk (10-
12) Moderate Risk (13-14); low Risk (15-16). (Pancorbo-Hidalgo PL 2006) 
• by origin (domicile vs. other settings) 
For all tests, a p <0.05 will be considered significant. 
The statistical analysis will be done using the "Statistical Package for the Social Sciences" 
(SPSS) software version 15.0 (SPSS Inc., Chicago, USA) 
 
Possible deviations from the protocol and / or critical issues 
and related behavior to be followed in all situations 
• If the dedicated nurse, during the daily inspection, realizes that the sacral MSP (in the 
patients of the experimental arm) has been removed without being positioned anymore, he 
provides to reposition it, marking in the CRF that the patient for that day remained without. 
• If instead the MSP is present and the patient belongs to the control group, the dedicated 
nurse reports the violation of the CRF randomization but leaves the MSP and treats the patient 
as reported for the experimental group. At the analysis of the results, if these violations have 
occurred, we will proceed in addition to the analysis for Intention to Treat also for Protocol. 
• If the patient is replaced by a different MSP (different brand) than the one in the studio, the 
dedicated nurse replaces it and marks the problem in CRF.  
Safety / risk assessments for participants: 
Patients are treated according to protocols and policy already in place (prevention and 
treatment of pressure injuries), and always in strict compliance with the Good Clinical 
Practice (GCP), there are no additional risks for the participants. The patient who eventually 
develops pressure ulcer will be treated as per hospital policy. If the patient develops a 
category I sacral lesion remains in the study. The event is marked in the data collection form 
(CRF). The rationale for this permanence involves both the difficulty in the differential 
diagnosis with skin redness (Sterner 2011) and the need to detect the secondary outcome 

 
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“Incidence of PD to the sacred category ≥ II ° according to the NPUAP scale”. The treatment 
of a category I injury involves the use of creams or at the most of ultrathin advanced dressing. 
If used in the control group patient it will be reported in CRF. If the patient belongs to the 
experimental group, no additional action is necessary. 
 
Duration of the study 
The project lasts a total of 12 months which includes the training of the staff of the centers 
involved, the recruitment of patients, the collection and processing of data. The time per 
patient is 7 days or until discharge if it occurs before the seventh day of admission. The date 
of the start of the trial will be considered to be the approval of the Ethics Committee for each 
center. 
The timing of the study includes the following subdivision: 
• Months 1 training of the centers involved 
• Months 2- 6- patient enrollment and database implementation 
• Months 7-12 - Data analysis and results dissemination 
 
Ethical and Administrative Aspects 
 
Informed consent 
Every potential participant will be fully explained the rationale of the study and will be given 
the opportunity to ask questions and receive answers to all his doubts. The informed consent 
form must be signed by the participant or a legally authorized representative prior to his 
participation in any of the procedures foreseen by the study. Patient documentation must be 
able to demonstrate that consent was given prior to participation in the study. A copy of the 
informed consent form must be left to the patient. The consent form, signed by the patient, 
must be kept at the site. 
 
 Approval by the Ethics Committee 

 
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This protocol, the informed consent form and all the necessary relevant information related to 
the study must be submitted to the Ethics Committee for evaluation and must be approved 
before the start of the study. The study will be conducted in accordance with international 
standards ISO 14: 155, with the Good Clinical Practice and with the national laws in force. In 
the event of amendments to the protocol (eg modification of the eligibility criteria, outcome, 
statistical analysis….) Specific amendment to the approval Ethics Committee will be required 
 
Confidentiality, Data Management, and Property of Results 
Adequate documentation will be maintained for everything concerning the patient's clinical 
data, work sheets, nursing notes, documentation and treatment of adverse events (CRF and 
nursing record) and study interruption. The confidentiality of the patient's sensitive data is 
guaranteed by the Investigator. The data is the property of the researchers. The data collected 
in the CRFs will be entered into a computerized and anonymous database. 10% of the CRFs 
will be randomly checked. The level of accuracy will be considered if more than 2% of input 
errors are not detected. The verification will be done by the Nursing and Allied Profession 
Research Unit of the IRCCS Rizzoli Orthopedic Institute. 
 
 Publication of Results 
The main investigator undertakes to produce the final report, publish all the data collected as 
described in the protocol and ensure that the data is reported responsibly and consistently. 
In particular, the publication of the data deriving from this study will take place regardless of 
the results obtained. 
The transmission or dissemination of the data, through scientific publications and / or 
presentation at congresses, conferences and seminars, will take place exclusively following 
the merely statistical elaboration of the same, or in any case in an absolutely anonymous 
form.  
References 
 
A Jaul, E., Menczel, J., 2015. A comparative, descriptive study of systemic factors and 
survival in elderly patients with sacral pressure ulcers. J. Ostomy Wound Manage. 61 (3), 20-
6. 
 

 
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Ver  1.0 del 28/11/2018 
 
B Jaul, E., Calderon-Margalit, R., 2015. Systemic factors and mortality in elderly patients 
with pressure ulcers. Int Wound J. 12 (3), 254-9.  
 
Bernabei, R., Manes-Gravina, E., Mammarella, E., 2011. Epidemiologia delle piaghe da 
decubito. G Gerontol. 59, 237-43. 
 
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). Cambridge Media: Osborne Park, Western Australia; 
2014. 
 
Clark, M., Black, J., Alves, P., Brindle, C., Call, E., Dealey, C., Santamaria, N., 2014. 
Systematic review of the use of prophylactic dressings in the prevention of pressure ulcers. Int 
Wound J. 11 (5), 460-71. 
 
Moore, Z.E.H., Webster, J., 2013. Dressing and topical agents for preventing pressure ulcers 
(Review). Cochrane Database Syst Rev. 8, CD009362. 
 
Santamaria, N., Gerdtz, M., Sage, S., Mccann, K., Freeman, A., Vassiliou, T., DeVincentis, 
S., Ng, A.V.V., Manias, E., Liu, W., Knott, J., 2015. A randomized controlled trial of the 
effectiveness of soft silicone multi-layered foam dressing in the prevention of sacral and heel 
pressure ulcers in trauma and critically ill patients: the border trial. Int Wound J. 12 (3), 302-
8. 
 
Kalowes, P., Messina, V., Li, M., 2016. Five-Layered Soft Silicone Foam Dressing to Prevent 
Pressure Ulcers in the Intensive Care Unit. Am J Crit Care. 25 (6), e108-e119. 
 
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;1–8.  
 
Call E, Pedersen J, Bill B, Black J, Alves P, Brindle CT, Dealey C, Santamaria N, Clark M. 
Enhancing pressure ulcer prevention using wound dressings: what are the modes of action? 
Int Wound J 2015; 12: 408-13.   
 
Matsuzaki K, Kishi K. Investigating the pressure-reducing effect of wound dressings. J 
Wound Care 2015; 24: 512, 514-7.   
 
Miller SK, Sharma N, Aberegg LC, Blasiole KN, Fulton JA. Analysis of the pressure 
distribution qualities of a silicon border foam dressing. J Wound Ostomy Continence Nurs 
2015; 42: 346-51.  
 
Young S, Bielby A, Milne J. Use of ultrasound to characterize the fluid-handling 
characteristics of four foam dressings. J Wound Care 2007; 16: 425-8, 430-1. 
 

 
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Ver  1.0 del 28/11/2018 
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: 268, 270-1, 273-5.   
 
Black J, Clark M, Dealey C, Brindle CT, Alves P, Santamaria N, Call E. Dressings as an 
adjunct to pressure ulcer prevention: consensus panel recommendations. Int Wound J 2015; 
12: 484-8.  
 
Palese A, Trevisani B, Guarnier A, Barelli P, Zambiasi P, Allegrini E, Bazoli L, Casson P, 
Marin M, Padovan M, Picogna M, Taddia P, Salmaso D, Chiari P, Marognolli O, Federica C, 
Saiani L, Ambrosi E. Prevalence and incidence density of unavoidable pressure ulcers in 
elderly patients admitted to medical units. J Tissue Viability. 2017 May;26(2):85-88. doi: 
10.1016/j.jtv.2017.03.003.  
 
Dasgupta A, Lawson KA, Wilson JP. Evaluating equivalence and noninferiority trials. Am J 
Health Syst Pharm. 2010 Aug 15;67(16):1337-43. doi: 10.2146/ajhp090507 
 
Walker R, Huxley L, Juttner M, Burmeister E, Scott J, Aitken LM. A Pilot Randomized 
Controlled Trial Using Prophylactic Dressings to Minimize Sacral Pressure Injuries in High-
Risk Hospitalized Patients. Clin Nurs Res. 2017 Aug;26(4):484-503. doi: 
10.1177/1054773816629689. Epub 2016 Feb 12. 
 
Levy A, Gefen A. Computer Modeling Studies to Assess Whether a Prophylactic Dressing 
Reduces the Risk for Deep Tissue Injury in the Heels of Supine Patients with Diabetes. 
Ostomy Wound Manage. 2016 Apr;62(4):42-52. 
 
Santamaria N, Gerdtz M, Kapp S, Wilson L, Gefen A. A randomised controlled trial of the 
clinical effectiveness of multi-layer silicone foam dressings for the prevention of pressure 
injuries in high-risk aged care residents: The Border III Trial. Int Wound J. 2018 Apr 10. doi: 
10.1111/iwj.12891.  
 
Levy A, Frank MB, Gefen A. The biomechanical efficacy of dressings in preventing heel 
ulcers.  
J Tissue Viability. 2015 Feb;24(1):1-11. doi: 10.1016/j.jtv.2015.01.001. Epub 2015 Jan 19. 
 
Richard-Denis A, Thompson C, Mac-Thiong JM. Effectiveness of a multi-layer foam 
dressing in preventing sacral pressure ulcers for the early acute care of patients with a 
traumatic spinal cord injury: comparison with the use of a gel mattress. Int Wound J. 2017 
Oct;14(5):874-881. doi: 10.1111/iwj.12710.  
 
Pancorbo-Hidalgo PL, Garcia-Fernandez FP, Lopez-Medina IM, Alvarez-Nieto C. Risk 
assessment scales for pressure ulcer prevention: a systematic review. J Adv Nurs. 2006 
Apr;54(1):94-110. 
 
Sterner E1, Lindholm C, Berg E, Stark A, Fossum B. Category I pressure ulcers: how reliable 
is clinical assessment? Orthop Nurs. 2011 May-Jun;30(3):194-205; quiz 206-7. doi: 
10.1097/NOR.0b013e318219ae77. 
 
 
 

 
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INFORMATION SHEET 
 
Dear Madam / Sir____________________________________________ 
at the Rizzoli Orthopedic Institute IRCCS of Bologna is planning a medical-scientific 
research entitled: Effectiveness of the use of multilayer polyurethane foam dressing in the 
sacral area, in addition to standard care, for the prevention of pressure ulcer in patients at risk. 
The study is of a multi-center nature, ie other hospitals and treatment centers in Italy are 
involved. 
To carry out this research we need the collaboration and availability of people who, like you, 
satisfy the scientific requirements suitable for the evaluation that will be performed. However, 
before you make the decision to accept or refuse to participate, please read carefully, taking 
all the time you need, these pages and ask us for clarification if you do not understand or need 
further clarification. Furthermore, if he wishes to do so, before deciding, he can ask an 
opinion to his family or to a trusted doctor. 
What is this study proposed for? 
The general objective of the study is to evaluate whether applying a polyurethane foam to the 
sacrum (it is a small soft sponge that is placed in the area of the sacrum held by a light 
plaster), in addition to the usual care, the probability of developing pressure injuries (wounds 
in the skin) and their severity. If you do not apply the soft sponge (polyurethane foam), the 
nurse of the department puts in place the care that you always do to avoid the formation of 
injuries: She often changes position if she cannot do it alone / a, The put a special mattress 
(antidecubitus) and guarantees you the cleaning to reduce the presence of moisture on the 
skin. 
What does your participation in this study involve? 
In case you decide to participate in the study, the experimental design of this research foresees 
that for a group of patients chosen at random (as would be done by throwing a coin) this 
sponge will be applied in addition to the usual preventive care during the first 7 days of 
hospitalization and for another group will be implemented only in the usual assistance (see 
description below). During the first 7 days of hospitalization, a nurse will check his/her skin 
and write down his characteristics and the assistance you received in the previous 24 hours in 
the data collection form (this information is always written in a folder). Moreover, if it 
belongs to the group of patients in which the sponge is applied (polyurethane foam), always 
on a daily basis, a nurse will also check whether it is still attached, dry and clean and will 
raise a border to examine the underlying skin . In this way, at the end of the study, it will be 
possible to understand whether using this sponge in addition to the usual preventive care 
reduces the probability of developing pressure injuries and their severity. Apart from the 
application and monitoring of the sponge by the nurse, you will not be asked and done 
anything other than what is already foreseen by your treatment plan. 
To say that he will be "randomly chosen" means that, if he agrees to participate in the study, 
the nurse will open an envelope inside which it will be written whether it was assigned to the 
sponge group (polyurethane foam) or to the group of usual care. The envelopes are reserved 
and no one in the ward knows what it contains until they are opened. 
The study will last 4 months and you will be involved only in the first 7 days of your stay or 
until you are discharged. Forty patients will participate in this research in this hospital, which 
will be chosen from all those who are in the same clinical condition. 

 
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If you agree to participate in this study you will be subjected to a first assessment to verify 
that your condition meets the criteria required by the study. If so and if you have agreed to 
participate in the study you will be asked to sign this form and nothing else. 
Participation in the study does not entail any additional expenses for you compared to the 
normal clinical routine foreseen by this structure. 
What other treatments are available? 
No other experimental treatment is foreseen and you will be treated as normally foreseen in 
the assistance practice for patients with your pathology. If new information is published in the 
scientific literature relating to this treatment, during the conduct of the study, it would be 
interrupted. 
What are the benefits you can receive by participating in this study? 
The following benefits can be expected from participation in this study: possible decrease in 
the onset of pressure injuries and their severity. 
What are the risks of participating in the study? 
Participation in the study does not involve additional risks linked to the possible use of 
polyurethane foam as it is one of the advanced dressings for the treatment of pressure injuries. 
If data becomes available that may influence your willingness to continue participating in the 
study, you will be promptly informed. 
Am I obliged to participate? 
You are free not to participate in the study. In this case, however, you will receive all the 
standard therapies provided for your pathology, without any penalty, and the doctors and 
nurses will continue to follow you with appropriate care. Your participation in this research 
program is completely voluntary and if you have agreed to participate, you can still withdraw 
from the study at any time. 
Will I have to incur costs to participate in the study? 
Participation does not entail any cost for the patient. 
Information about the results of the study 
If you request it, at the end of the study the results in general and in particular those 
concerning you may be communicated to you. 
Further information 
The following personnel will be available for further information and communications during 
the study: 
Cristiana Formi nurse responsible for research, telephone 0516366694 
 
You can request information on the rights of study participants at the Local Secretariat of the 
AVEC Ethics Committee, via Pupilli 1, Rizzoli Orthopedic Institute 40136 Bologna, tel. 051 
6366480 - Email: segreteria.ce@ior.it 
The protocol of the study that was proposed to you was drafted in compliance with the 
European Union Good Clinical Practice Rules and the current revision of the Helsinki 
Declaration and was approved by the Ethical Committee of the Emilia Wide Area Center of 
the Emilia-Romagna Region (CE -AVEC). 
 

 
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DECLARATION OF CONSENT 
 
I, the undersigned: _______________________________________________ 
I declare that I have received from Doctor________________________________ 
comprehensive explanations regarding the request to participate in the experimental study in question, 
according to what is reported in the information sheet attached here, a copy of which was delivered to 
me with sufficient notice (date ________________). 
I also declare that I was able to discuss these explanations, to ask all the questions that I considered 
necessary and to have received satisfactory answers, as well as to have had the opportunity to inform 
me about the details of the study with a person I trusted. 
I therefore freely agree to participate in the trial, having fully understood the meaning of the request 
and having understood the risks and benefits involved. 
 
 I accept 
 I do not accept  
 
________________ ___________________________________ 
Date Signature of the patient 
________________ ___________________________________ 
Date Signature of the nurse who informed the patient 
[In case the patient cannot read and / or sign] 
 
I, the undersigned: _________________________________________________ 
I testify that Nurse __________________________________________ 
has fully explained to Mr. _________________________________ 
 
the characteristics of the experimental study in question, as reported in the information sheet attached 
herein, and that the latter, having had the opportunity to ask all the questions he deemed necessary, 
freely accepted to join the study. 
 
________________ ___________________________________ 
Date Signature of the independent witness