Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Control Clinical Trial
Phase: NA
Conditions: Cardiac Surgery Subjects, Pressure Ulcer Prevention, Pressure Ulcer of Skin, Pressure Ulcer
Sponsor: King Abdullah Medical City

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 1 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
 
Project Title:  
Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
 
Acronym 
 
Version: version: 2 
 
Principal Investigator: Ebtisam Abdellatif Ebrahim  
 
Sponsor: King Abdullah Medical City in Holy Capital 
 
Introduction 
The application of standard evidence-based prevention interventions can decrease the incidence 
of pressure injuries (PIs). However, the development of serious PIs in high-risk patients in the early 
postoperative period remains a significant clinical challenge. Following surgery, PIs that appear within 
1 to 5 days are often deep-tissue pressure injuries (DTPIs) [1].  
The etiology of DTPIs remains a topic of ongoing discussion among experts, and a 
comprehensive understanding of the underlying pathophysiological mechanisms has yet to be achieved. 
One commonly accepted hypothesis posits that the occurrence of DTPIs can be attributed to the 
application of pressure or shear stresses, or a combination thereof, resulting in cellular deformation and 
eventual necrosis. The DTPIs exhibit a distinctive complexity due to the co-occurrence of ischemia and 
mechanical stress, thereby expediting the consequent harm [2,3] 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 2 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
DTPIs exhibit a discernible pattern of evolution. Initially, the affected area manifests abruptly as 
intact skin that exhibits discoloration, either in the form of purple or hyperpigmentation [2]. The lesions 
evolve into slender vesicles atop a dusky ulceration site, transformingrotic black eschar. Subsequently, 
the DTPI becomes unsealed, exposing a pressure injury that has penetrated through the entire thickness 
of the skin and underlying tissues, indicating a stage 3 or 4 injury [3,4]. According to a study conducted 
in 2013, it has been observed that wounds of this nature have the potential to heal without any loss of 
tissue. Nevertheless, it is imperative to provide sustained care and attention to prevent any deterioration 
[5]. 
Patients undergoing cardiac surgery are among those at the highest risk of developing PIs, with 
an incidence as high as 29.5% [6]. Among patients undergoing cardiac surgery, specific risk factors for 
PI include protracted exposure to pressure during lengthy surgical procedures, vascular disease, and/or 
postoperative vasopressor use [7]. The high incidence of PI among cardiac surgery patients suggests that 
conventional methods for preventing PI are inadequate for this population. 
There are an increasing number of studies evaluating the efficacy of different dressings (typically 
multilayer foam dressings) in preventing pressure ulcers (PIs) of the sacrum, heel, and those related to 
medical devices in ICU and trauma patient populations [8,9]. Recent high-quality randomized controlled 
trials demonstrated that the use of specialty foam dressings over the sacrum can reduce the incidence of 
pressure ulcers in intensive care unit (ICU) patients and high-risk nursing home residents [10,11]. 
Although limited in design and/or sample size, additional research and quality improvement 
investigations support the efficacy of this intervention in preventing the formation of PIs [12]. The 
National Pressure Ulcer Advisory Panel, in collaboration with European and Pan-Pacific peer 
organizations, added a recommendation (with a "B" strength of evidence) to "consider applying a 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 3 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
polyurethane foam to bony prominences (e.g., heels, sacrum) for the prevention of pressure ulcers in 
anatomical areas frequently subjected to friction and shear" in its 2014 guidelines [13]. 
The market offers a variety of dressings distinguished by their composition (hydrocolloid, 
polyurethane foam, etc.), thickness, and dimension. Several in vitro studies compare the ability of the 
most popular dressings on the market regarding the redistribution of pressure, [15-17] the management 
of fluids/hydration and the application of friction, which are the primary factors in the onset of PU. In 
these in vitro investigations, the material that appears to be the most effective overall is polyurethane 
foam [18], particularly when composed of multiple layers [19]. In two recent clinical investigations 
involving intensive care unit (ICU) patients, the use of multi-layer foam dressings was found to be an 
effective method of preventing PU [20]. 
A systematic review revealed that the prevalence of pressure ulcers among surgical patients 
increased from 0.3% to 57%. In a study of Brazilian patients undergoing elective surgery, the prevalence 
of pressure ulcers reached 25 % [21]. 5–53.4% of hospital-acquired pressure ulcers are associated with 
protracted or multiple surgical procedures, according to studies [22]. In the operating room of a private 
hospital in western Indonesia, the incidence of pressure ulcers has increased from one case in 2018 to 
four cases in 2020. 
Despite the fact that the data support the use of dressings as a preventative intervention, the 
reviewers deemed them inconclusive because of the flaws in the study designs, which increased the 
possibility of bias. Both evaluations recommended further methodologically rigorous research to 
generate proof of the effectiveness and kind of dressing to use for prevention as their conclusion. King 
Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and 
both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 4 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex 
dressing for prevention of pressure ulcer in operating room. 
OBJECTIVES:  
The primary objective of this study is to: 
 - To evaluate the efficacy of using polyurethane foam (pink Pad) versus Mepilex dressing in pressure 
ulcer prevention for patients in operating room. 
Secondary Objectives 
- 
Identifying the incidence of post-operative pressure injury for cardiac surgery patients at king 
Abdullah medical city. 
 Objective measures 
For the primary objective  
Pressure ulcer incidence will be assessed by using Bates–Jensen Wound Assessment Tool (BWAT) after 
operation then day 3 and day 7 for both treatments. 
For the secondary objective  
The occurrence of pressure ulcer will be documented in data collection then calculated. 
Research Design:    
 Open label randomized control clinical trial study with a pilot study-using questionnaire.  
Inclusion Criteria:  
 Subjects ≥ 18.  
 Willing to participate. 
 Patients undergoing cardiac surgery.  
 Patient who is at risk for PU development as measured with Braden scale.  

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 5 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
 Patient who has skin intact and having a life expectancy greater than 72 hours as per clinical 
judgement.  
Exclusion Criteria:  
 Subjects under 18  
 Not consenting to participate  
 Patients with suspected hypersensitivity reactions to any of the dressing formulation’s 
ingredients. 
 Patients who are unable to continue the study because of death or change in the care setting. 
Randomization 
Electronic randomization will be used as a simple technique of randomization. The randomization 
list was generated electronically using R and the Random Allocation Rule by a member of the research 
center who was not actively involved in the trial's enrollment and recruitment. A member of the research 
center will identify the participant for this concealment. To determine which treatment a participant will 
receive, an allocation sequence and envelopes containing the sequence will be generated. Each envelope 
will not be opened until the patient has consented and been enrolled in the study. 
Blinding 
Open label study as True blinding for patients and the research nurse who will apply the dressing 
and Polyurethane foams (Pink Pad) will be difficult as there is a significant difference between the two 
treatment methods in presentation. Moreover, the skin imprint after the foam removal made it impossible 
to blind the outcome assessor.  
Study Procedure: 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 6 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
There are two types of intervention available in King Abdullah medical city for operating room 
pressure ulcer prevention. Polyurethane foams (Pink Pad) are a single use system for use in surgical 
procedures. The system consists of a proprietary formulation for the pink foam pad, non-woven lift 
sheet, body straps, head rests, and boot liners. It aids hospital facilities in providing a safe and effective 
method of management of the patient for pressure ulcers and non-movement for patients in the 
Trendelenburg position.  
Mepilex Border Sacrum dressings are self-adherent, multilayer foam dressings designed for 
use on sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care 
protocols for pressure ulcer prevention. 
After getting official permission from KAMC IRB, the subject will be randomized using 
electronic randomization 1:1 ratio. The randomization list was generated electronically through R using 
the Random Allocation Rule. Patients will equally be allocated into 2 groups randomly. The 
polyurethane foam group and Mepilex Border Sacrum dressings group. 
Standard PUs preventive care - All included patients received standard PU prevention 
according to hospital protocols, based on contextualization and adaptation of International guidelines ( 
European Pressure Ulcer Advisory Panel, 2021 ), which involved: assessment of PU risk through the 
Braden Scale at hospital admission, every seven days and when clinically indicated (for example after 
surgery); full skin assessment during every shift, three times per day combined with routine positioning 
every 2 h or when required; use of active support surfaces (higher- specification foam mattress or 
dynamic anti-decubitus mattress) in case of Braden < 16, aiming at preventing damaging tissue 
deformation and providing an environment that enhances perfusion of at risk tissues; incontinence skin 
care. 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 7 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
Prior to surgery, Mepilex Border Sacrum dressings 20 X 20 (Molnlycke Health Care) will be 
applied to the patient's sacrum for Mepilex Border Sacrum dressings group and polyurethane foam will 
be used to the patient's sacrum for polyurethane foam group. A nurse in the preoperative patient 
receiving area will apply the Mepilex Border Sacrum dressings. The perioperative nurse will examine 
the dressing in the operating room to ensure its integrity. If the perioperative nurse observed any 
alterations to the original application, such as rolling or displacement, she will reapply it. If the dressing 
is not applied by the nurse before transferring the patient to the operation room the perioperative nurse 
will apply it. For polyurethane foam (pink Pad) it will be used only by operating room nurses as it is 
available only in the operating room. Both types of intervention will be available in the operating room. 
Patient will be examined by head nurse of wound management team after the operation then at 
day 3- and 7-days post operation. The dressing should be removed after 7 days post operation or if there 
is any clinical indication for removal. If a patient is discharged before 7 days post operation for any 
reason the head nurse of wound management team will examine the patient before discharge. Follow up 
will be for maximum 7 days post operation for each subject.   Any patient will be unable to continue the 
study because of death or change in the care setting will be excluded from the study. 
Pilot study: 
It will conduct before data collection on 10% of patients to explore feasibility for future RCT, 
the efficiency, internal validity and fundamentally, the delivery of proposed trial and identify barriers 
and facilitators. Mepilex Border Sacrum dressings will be applied to 4 patients before the procedure 
and Polyurethane foams (pink pad) will be applied to 4 patients before the procedure. The data 
collection tool will be tested, and these patients will be excluded from the study, after completion the 
patient will have routine care for pressure ulcer treatment. 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 8 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
Sample Size calculation:  
A Convenience sample of 80 cardiac surgery patients who are expected to have long procedures (more 
than 4 hours) will be included in this study. These patients will be divided randomly into two groups; 
the polyurethane foam (pink pad) group (40 patients), and Mepilex Border Sacrum dressings group (40 
patients).  
Ep-info program was used to find sample size using the following information:   
Population size = 90 patients.  
Expected frequency=50%.  
Acceptable error=5%.  
Confidence coefficient=99%. 
Minimal sample size=79. 
 
 Duration of the Study: 6 months in total. The enrolment will be for 20 days. Follow up will be for 
maximum 7 days post operation for each subject. A period of 4 months will be for analysis and closing. 
Setting:  
This study will be carried out at the operating room, cardiac surgery intensive care unit and cardiac 
surgery ward at King Abdullah Medical City, Holy Makkah. 
 
Data Collection and Management:   
After the official approval from KAMC IRB and the local authority approval. All the research 
nurses had taken part in designing the protocol and had specific training in research methodology and 
prevention, treatment, and classification of PU. The principal investigator will convene a meeting with 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 9 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
the study team to provide an overview of the study's implementation, with the aim of ensuring adherence 
to quality standards and regulatory requirements. Researchers will explain the study to the participants 
and take written consent if they want to participate. In cases where a patient is unconscious, written 
consent will be obtained from their Legally Acceptable Representative in accordance with legal 
protocols. Voluntary and anonymous participation will be ensured. In case of passing away the collected 
data will not be used, and safety reports will be submitted as per the local gaudiness. The data collection 
sheets will be securely stored in a locked file cabinet under the custody of the researchers. 
Study outcome measurement: 
Data will be collected through one tool that will be collected by the assessor. It will include two 
sections as follows:  
Section I: Patients’ demographic data 
This section was developed by the PI based on relevant literature. It will include demographic and 
medical history data will be collected from the patients’ medical records without identifier such as age, 
sex, body mass index, history of smoking, diagnosis at the time of admission, and laboratory parameters 
including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) will be recorded. 
Nutritional status of patients will be evaluated considering route of nutritional support (enteral or 
parenteral). Subject will be identified via serial codes. 
Section II: Pressure ulcer assessment.  
If there is any incidence of pressure ulcer this section will be recorded. The most common location 
for PI is the sacrum, which is particularly vulnerable to injury and difficult to treat (23). This section will 
be adopted from Bates-Jensen 2010 [27]. The Bates–Jensen Wound Assessment Tool (BWAT) will be 
used to assess pressure ulcers. It is a validated wound assessment tool which is used in many healthcare 
settings for wound assessment. BWAT is straight forward to use and allows nurses to have an objective, 
comprehensive assessment of wounds. It consists of 13 items to evaluate wound size, type and depth, 
amount of necrotic tissue, amount and characteristics of exudate, the presence of granulation tissue, 

Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 10 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
epithelialization, and peri- 6 wound skin. PU length and width was measured with a disposable ruler and 
expressed as cm2. The patient will be examined after operation then day 3 and day 7. Follow up will be 
for maximum 7 days post operation for each subject. If the any patient will be unable to continue the 
study because of death or change in the care setting the researcher will be excluded from the study. 
Statistical Analysis Plan 
Data obtained from the study will be coded and transformed into coding sheets. The results will be 
checked. Then, the data will be entered into SPSS system files (SPSS package version 22). Following 
data entry, checking and verification will be done to avoid errors during data entry. Finally, analysis and 
interpretation of data will be conducted. Categorical variables will be expressed as number and 
percentage while continuous variables will be expressed as mean and standard deviation.  
Publication: 
The results of this research will be published to either national or international publications. The 
main credit in publication will go to King Abdullah Medical City in Holy Capital and to the principal 
investigator and co-investigators. Others who have contributed less substantially will have an 
acknowledgement in the manuscript.  
Ethical Part & Confidentiality: 
 Ethical approval will be sought from KAMC IRB, local authority as applicable and will do study 
accordingly. Researchers will explain the study to the participants and take written consent if they want 
to participate. The participation will be voluntary and anonymous.  
 
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Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 11 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
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Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 12 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
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Effectiveness of polyurethane foam dressing compared with Mepilex dressing for 
pressure ulcer prevention in operating room: A randomized control clinical trial. 
- 13 - 
Title: Effectiveness of polyurethane foam (pink pad) compared with Mepilex dressing for pressure ulcer prevention in operating room 
Version: 2.0 (20-Jun-2023) 
Effective date: 15-Aug-2023 
Expiration date: 15-Aug-2024 
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