Foam Dressings For Treating Pressure Ulcers
What is the aim of this review?
The aim of this review was to find out whether foam dressings have any advantages or disadvantages in healing pressure ulcers compared with other dressings . Researchers from Cochrane collected and analysed all relevant studies to answer this question and found nine relevant studies.
There is no clear evidence from any of the studies included in this review that foam dressings are more effective at healing pressure ulcers than other types of dressings or that foam dressings are more cost effective than other dressings. This is due in part to the low quality of the studies, many of which had small numbers of participants and did not provide accurate details of their methods.
What was studied in the review?
Pressure ulcers are wounds that develop on bony parts of the body such as the heels, hips and lower back. Sitting or lying in the same position for long periods can cause damage to the skin and underlying tissue. People at risk of developing pressure ulcers include those with limited physical mobility such as people with spinal cord injuries, older people, or those ill in hospital.
What are the main results of the review?
Generally, the studies we found did not have many participants and the results were often inconclusive. Overall the evidence that exists is of very low quality.
How up to date is this review?
We searched for studies that had been published up to February 2017.
We present data for four comparisons.
Kce1601: A Medical Device Trial To Evaluate The Use Of A Silicone Adhesive Multilayer Foam Dressing As Prevention For Pressure Ulcer Development In Hospitalised Patients
Despite preventive measures, pressure ulcers occur in more than 1 in 10 hospitalised patients. Pressure ulcers vary from non-blanchable erythema to full thickness tissue loss with exposed bone, tendon or muscle. Pressure ulcers are caused by pressure or pressure combined with shear . To prevent pressure ulcers, regular repositioning and floating heels were recommended. Next to this, a broad range of mattresses and cushions, with the aim of reducing the amount of pressure, are used. Recently, interest is growing in the use of foam dressings as an additional measurement to prevent pressure ulcers. Foam dressings act as a cushion, reduce pressure and shear, and absorb excessive moisture. Similar dressings are already being used for the treatment of a range of skin lesions. Available studies claim the promising effect of foam dressings in reducing pressure ulcer risk. However, most studies were of low quality and restricted to critically ill patients. Furthermore, the use of foam dressings for pressure ulcer prevention is associated with additional costs.
The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and hips in addition to hospital standard prevention protocol, reduce pressure ulcer incidence compared to standard pressure ulcer prevention alone, in at risk hospitalised patients.
When To Use Mepilex Border Heel
Mepilex® Border Heel is specifically designed to fit the heel. The five-layer absorbent foam structure effectively manages exudate and the wound environment. So you can use it in the treatment of exuding wounds such as pressure ulcers, diabetic foot ulcers, heel ulcers, traumatic wounds, and other secondary healing wounds.
Pressure ulcer prevention
Mepilex Border Heel has been proven to prevent pressure ulcers . You can apply the dressings prophylactically for at-risk patients , such as the immobile, those with poor skin perfusion and impaired skin condition, in emergency rooms, in intensive care, or before and during long surgical interventions. Scientific studies have demonstrated that Mepilex Border Heel has the ability to impact four extrinsic factors that can contribute to developing pressure ulcers: by minimising and redistributing shear, redistributing pressure, reducing friction and maintaining an optimal microclimate .
Note: using dressings as a prophylactic therapy does not replace the need a comprehensive pressure ulcer prevention protocol.
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Silicone Adhesive Multilayer Foam Dressings To Prevent Pressure Ulcer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|First Posted : February 22, 2018Results First Posted : April 26, 2021Last Update Posted : April 26, 2021|
- Study Details
The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and greater trochanter in addition to standard prevention reduce pressure ulcer incidence category II, III, IV, Unstageable and Deep Tissue Injury compared to standard pressure ulcer prevention alone, in at risk hospitalised patients. In particular, this trial extends previous trial results obtained in ICU setting. Therefore, only a maximum of 25% of patients will be recruited from ICU settings.
|Pressure Ulcer||Device: Allevyn® brand silicone adhesive multilayer foam dressingsDevice: Mepilex® brand silicone adhesive multilayer foam dressings||Not Applicable|
A multicentre randomised controlled open label parallel group medical device trial in approximately 8 hospitals in Belgium.
Patients will be randomly allocated to three study arms based on a 1:1:1 allocation:
Study arm 1 :
Study arm 2 :
Study arm 3 :
|Experimental: Study Arm 1|
Pressure Ulcer Prevention And Treatment: Use Of Prophylactic Dressings
Accepted for publication 5 March 2015
11 October 2016Volume 2016:3 Pages 117121
Kathleen Reid,1 Elizabeth A Ayello,2 Afsaneh Alavi,3
Pressure ulcers are a major cause of mortality, morbidity, patient suffering, and cost on the health care system worldwide. The management of pressure ulcers is a compounding challenge to health care professionals across disciplines. Individuals who acquire pressure ulcers often require long-term interventions, representing a large economic burden to the health care system. It has been estimated that in Australia, these injuries increase the length of hospital stay and subsequently incur $285 million in cost annually.1 Since 2008, the Centers for Medicare and Medicaid Services no longer reimburses American hospitals at a higher rate for any pressure ulcer that occurs during a patients hospitalization, which provides a strong financial stimulus for pressure ulcer prevention protocols to be implemented.2 Indeed, the profound impact of pressure ulcers on the emotional, physical, mental, and social domains of life has been shown in different studies.3 Current management strategies target pressure-relieving surfaces: patient repositioning, nutritional support, and application of protective dressings to prevent pressure injuries. Dressings are accessible and easily implemented devices however, they can also contribute to high health care costs. Therefore, it is important to evaluate their efficacy.
Prophylactic role of dressings
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Key Challenges And Learning Points
The key challenges faced by the EAC and the company were the issues with generalisability and uncertainty surrounding the clinical evidence. Although a reasonable body of evidence exists for Mepilex Border dressings, all of the clinical trials were conducted outside of a UK setting. This raised uncertainty around whether the evidence from these trials could be generalised to the UK NHS, due to potential differences in standard care pressure ulcer prevention protocols and the baseline incidence rate of pressure ulcers. Standard care prevention protocols were not always clear in the reporting of each of the clinical trials, although in cases where they were clear, it was judged that they were consistent with standard care in the UK. Expert advice and the existence of national prevention guidelines further supported the idea that the comparator in the trials was well matched to the decision problem . The baseline incidence of pressure ulcers estimated for the UK NHS setting by the EAC was also well aligned with the three RCTs on which the meta-analysis was based, and therefore, the scope to benefit from Mepilex Border dressings was judged to be broadly similar in a UK NHS setting.
When To Use Mepilex Border Sacrum
Use Mepilex Border Sacrum for medium-to-high exuding sacral wounds, such as pressure ulcers or surgical excision of pilonidal cysts. The dressing maintains a moist wound environment, which supports debridement, so you might see an initial increase in the wound size. This is normal and to be expected.
Pressure ulcer prevention
A recent randomised controlled trial in the USA revealed a statistically significant effect of Mepilex Border Sacrum in reducing the incidence of hospital acquired pressure ulcers by 88% You can apply the dressing prophylactically for at risk patients , such as the immobile, those with poor skin perfusion and impaired skin condition, in emergency rooms, in intensive care, or before and during long surgical interventions. Scientific studies have demonstrated that Mepilex Border Sacrum has the ability to impact on four extrinsic factors that can contribute to developing pressure ulcers: by minimising and redistributing shear, redistributing pressure, reducing friction, and maintaining an optimal microclimate .
Note: the use of dressings as part of a prophylactic therapy does not preclude the need to continue to develop and follow a comprehensive pressure ulcer prevention protocol.
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Background To The Indication And Devices
Pressure ulcers are localised injuries to the skin and/or underlying tissue as a result of pressure, or pressure in combination with shear . Pressure ulcers can range in severity and can be classified into the following categories or stages :
Stage 1 Intact skin with non-blanchable erythema of a localised area. Discoloration of the skin, warmth, oedema, hardness or pain may also be present.
Stage 2 Partial thickness loss of dermis presenting as a shallow open ulcer with a red/pink wound bed, without slough or bruising. It may also present as an intact or open/ruptured serum-filled blister.
Stage 3 Full thickness tissue loss. Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed. Some slough may be present. It may include undermining and tunnelling.
Stage 4 Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present. It often includes undermining and tunnelling.
Pressure ulcers can have a significant impact on a patients quality of life, both physically and psychologically. They can also lead to further health complications such as infection, extended hospital stays, restricted rehabilitation and restricted treatment options for other medical conditions .
All patients are at risk of pressure ulcers. However, Mepilex Border dressings have been indicated for use in people identified as either at risk or at high risk of developing a pressure ulcer.
Guy reports that risk factors for pressure ulcers include:
Dressings And Topical Agents For Preventing Pressure Ulcers
We reviewed the evidence about whether dressings and topical agents, like creams, can prevent pressure ulcers.
Pressure ulcers, also known as bed sores or pressure sores, are injuries to the skin or tissue underneath, or both. They develop as a result of sustained pressure on bony parts of the body. They are common among elderly people and those with mobility problems. They are often difficult to heal, expensive to treat and have a negative impact on people’s quality of life, so it is important to prevent them. Special mattresses, cushions, and regular changes of position are used for prevention. Dressings and creams are also widely used. We wanted to compare different dressings and topical agents and find out which were best at preventing pressure ulcers in people at risk of developing them. We also wanted to consider other outcomes, like pain, quality of life, and the cost to healthcare systems of the different treatments.
Quality of the evidence
The certainty of the evidence in the trials was low to very low. Additional trials at low risk of bias are needed to clarify the effect of dressings and topical agents in preventing pressure ulcers.
We searched for trials that had been published up to March 2017.
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