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 (for example due to sliding down in a seat). 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 (greater trochanter) in addition to hospital standard prevention protocol, reduce pressure ulcer incidence compared to standard pressure ulcer prevention alone, in at risk hospitalised patients.
| Summary of results |
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From February 2018 until December 2018, 1633 patients, included in 8 Belgian hospitals, were centrally randomised to one of the study groups: 542 (33.2%) to experimental group 1, 545 (33.4%) to experimental group 2, and 546 (33.4%) to the standard of care (SOC) group. Of the 1605 participants in the primary analysis, 77 (4.8%) developed a pressure ulcer category 2 or worse (sacrum, trochanters or heels); 4.0% in the treatment group and 6.3% in the SOC control group. In the treatment group (dressings) there was a significant reduction of the risk to develop a new pressure ulcer, meaning that patients in the treatment group had a 36% risk reduction of developing a new pressure ulcer compared to those in the SOC group. When the different locations were analyses separately, the effect was clearly seen for sacrum (from 4.8% to 2.8%), no clear effect was seen for heels (from 1.9% to 1.4%), and the incidence for trochanter was too low (only a single patient developed a pressure ulcer). The number needed to treat to prevent 1 pressure ulcer category 2 or worse on the sacrum is 50. While no serious adverse device effects were reported during the study, 33 adverse device effects were reported from 28 patients of the safety population (n=1077). Most common adverse device effects reported were classified as ‘mechanical skin injury’. In conclusion, this large multicentre trial showed no clear protective effect of multilayer dressings for pressure ulcers at heels or trochanter sites when applied in hospitalised at risk patients. This randomised trial confirmed previous reports that multilayer dressings reduce the incidence of sacral pressure ulcers in hospitalised patients in addition to standard of care, both on ICU as well as on other wards (number needed to treat of 50). A health-economic analysis was performed and showed the preventive use of silicone adhesive multilayer foam dressings on the sacrum, for a population similar to the pragmatic trial population, can be supported both from a clinical and economic point of view. |
| Title | The use of a silicone adhesive multilayer foam dressing as an adjuvant prophylactic therapy for pressure ulcer prevention: a multicentre randomised open label parallel group medical device trial in hospitalised patients at risk of pressure ulcer development. (KCE-16012) |
| Participants (P) | Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development |
| Intervention (I) | Study arm 1: Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith & Nephew (Allevyn® brand). Study arm 2: Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). |
| Control (C) | Study arm 3: No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left). |
| Outcome (O) | Incidence rate during the study period (maximum 14 days for any individual patient) of at least one new pressure ulcer category II, III, IV, Unstageable, Deep Tissue Injury (DTI) (briefly referred to as pressure ulcers category II or worse) on sacrum, heels and hips (greater trochanter) as judged on site. |
| Trial Design | Multicentre randomised open label parallel group medical device trial |
| Sample Size | 1662 patients in approximately 8 centres |
| Trial duration | 2 years |
| Budget | 2.750.000€ (incl. VAT) |
| Sponsor | KCE – Belgium Health Care Knowledge Centre |
| Chief Investigator | Prof Dr Dimitri Beeckman Department of Public Health University Centre for Nursing and Midwifery, Ghent University |
| Trial coordinator | Bénédicte Manderlier Department of Public Health University Centre for Nursing and Midwifery, Ghent University |
ClinicalTrials.gov NCT03442777
Commissioning workstream 2016
