Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital‐acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open‐label parallel‐group medical device trial*

Abstract

Funding sourcesThe Belgian Health Care Knowledge Centre (KCE) funded and sponsored the trial via the KCE Trials Programme (study ID KCE16012), a national public funding programme of noncommercial trials. No funding from the manufacturers of the study devices was received. Involvement of the sponsor included refinement of the study design and statistical analyses but they were not involved in data collection. KCE members reviewed the manuscript for statistical correctness and interpretation. The corresponding author had the final responsibility for the decision to publish.

Silicone adhesive multilayered foam dressings for pressure ulcer prevention

“…Interestingly, the authors report that no statistically significant difference was seen when dressings were applied to the heels. 6 This is consistent with findings from previous studies. 5 Prophylactic dressings may be efficacious but, as Beeckman et al note, 6 they are not a standalone intervention.…”

“…1 Such a bundle would incorporate the five key elements of (i) PU risk assessment, (ii) a structured and regular skin assessment, (iii) turning, repositioning and mobilization on an individualized schedule, (iv) reduction of pressure, friction and shear forces including the application of prophylactic silicone multilayered foam dressings and (v) facilitation of adequate nutrition. 7 In conclusion, the study by Beeckman et al 6 provides robust evidence for use of dressings in conjunction with standard PU prevention practices, as recommended in the recent international PU prevention and management guidelines. 1 This study provides important data to support clinician decision making in the judicial use of prophylactic silicone multilayered foam dressings when used in addition to standardized PU prevention bundles.…”

“…I concur with the authors that conjectural risk exists for clinicians to feel over-reliance or 'false security' when using the dressings, resulting in standard PU prevention practices being overlooked. Fortunately, this hypothetical was not reported in the study of Beeckman et al 6 or in other studies. 2,5 Prophylactic silicone multilayered foam dressings should be incorporated into standardized PU prevention regimens or bundles that align with international best practice guidelines.…”

“…4,5 Case reports and data from a retrospective study in children and adolescents under 18 years of age suggested considerable improvements in Psoriasis Area and Severity Index (PASI) score and Physician's Global Assessment (PGA) after a 6month treatment with FAE, using an adult dosage regimen. 6 In this issue of the BJD, Hamm et al report the results from the first randomized placebo-controlled phase IIIb study on the efficacy and safety of FAE in 134 children and adolescents between 10 and 17 years of age with moderate-to-severe plaque psoriasis. 7 Patients were randomized 2 : 1 to treatment arms A (FAE/FAE) or B (placebo/FAE).…”

“…5 However, the studies included in that review were notably conducted only in single-site settings. 5 In this issue of the BJD, Beeckman et al 6 present data from the first large, robust, pragmatic multicentre trial comparing the application of prophylactic silicone foam dressings (two dressings from different manufacturers). Block randomization was used to allocate patients into either a group using the silicone multilayered foam dressing and standard PU prevention practices, or a group using standard PU prevention practices alone, to assess the incidence of PUs of stage 2 or worse.…”