D Beeckman1,2,3, A Fourie1, C Raepsaet1, N Van Damme1, B Manderlier1, D De Meyer1, H Beele4, S Smet4, L Demarré5, R Vossaert5, A de Graaf6, L Verhaeghe7, N Vandergheynst7, B Hendrickx8, V Hanssens8, H Keymeulen9, K Vanderwee10, J Van De Woestijne11, S Verhaeghe1, A Van Hecke1, I Savoye12, J Harrison12, F Vrijens12, F Hulstaert12. 1. Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium. 2. School of Nursing & Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland. 3. School of Health Sciences, Örebro University, Örebro, Sweden. 4. Wound Care Centre, Ghent University, Ghent, Belgium. 5. AZ Sint-Elisabeth, Zottegem, Oost-Vlaanderan, Belgium. 6. Wound Care Support Team, Nursing Centre of Excellence, University Hospitals of Leuven, Leuven, Belgium. 7. AZ Maria Middelares, Ghent, Belgium. 8. University Hospital of Brussels (UZB), Department of Plastic Surgery, Brussels, Belgium. 9. OLV Ziekenhuis Aalst, Aalst, Oost-Vlaanderan, Belgium. 10. OLV van Lourdes Ziekenhuis Waregem, Waregem, West-Vlaanderan, Belgium. 11. AZ Groeninge, Kortrijk, West-Vlaanderan, Belgium. 12. Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium.
Abstract
BACKGROUND:Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). OBJECTIVES: To 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. METHODS: This 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. RESULTS: In 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). CONCLUSIONS:Silicone 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.
RCT Entities:
BACKGROUND:Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). OBJECTIVES: To 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. METHODS: This 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. RESULTS: In 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). CONCLUSIONS:Silicone 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.