Trial reportThe British journal of dermatology2021
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.
Trial report in The British journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03442777 (Silicone Adhesive Multilayer Foam Dressings as Adjuvant Prophylactic Therapy for Pressure Ulcer), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Silicone Adhesive Multilayer Foam Dressings as Adjuvant Prophylactic Therapy for Pressure Ulcer (PU) Prevention: a Multicentric Randomised Open Label Parallel Group Medical Device Trial in Hospitalised Patients at Risk of PU Development
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Efficacy of silicone foam dressings in preventing pressure injuries in the sacral and heel areas of patients: a meta-analysis.Frontiers in medicine · 2025Pooled it
- Dressings and topical agents for preventing pressure ulcers.The Cochrane database of systematic reviews · 2024Pooled it
- Prophylactic sacral protective dressings' effect on preventing pressure injury: A meta-analysis.International wound journal · 2022Pooled it
- Trial
- Prophylactic Sacral Dressing in Prevention of Pressure Injury among ICU Patients: A Systematic Review and Meta-analysis.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2025Review
- Nurses' Perspectives on the Use of Prophylactic Dressings to Prevent Pressure Injury: A Qualitative Study.Journal of clinical nursing · 2025Article
- Economic Evaluation of Multilayer Silicone-Adhesive Polyurethane Foam Dressing for the Prevention of Pressure Ulcers in at-risk Hospitalized Patients: US and Italian Perspective.International journal of health policy and management · 2024Article
- The frictional energy absorber effectiveness and its impact on the pressure ulcer prevention performance of multilayer dressings.International wound journal · 2024Review
- The efficacy of sacral foam dressing in preventing sacral pressure injury: A systematic review and meta-analysis.International wound journal · 2024Article
- Silicone adhesive multilayer foam dressings for preventing facial pressure injuries in COVID-19 patients in prone position.Journal of the Intensive Care Society · 2023Article
- Alternatives and preferences for materials in use for pressure ulcer prevention: An experiment-reinforced literature review.International wound journal · 2022Article
- The vision and scope of the prophylactic dressing standard initiative of the European Pressure Ulcer Advisory Panel and National Pressure Injury Advisory Panel.International wound journal · 2022Article
Corrections and comments
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Authors and funding
24 authors at 8 institutions in 3 countries.
Funding
Abstract
backgroundSilicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs).
objectivesTo determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone.
methodsThis was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites.
resultsIn the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49).
conclusionsSilicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.