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

Background: Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital‐acquired pressure ulcers (PUs). Objectives: Determine if silicone foam dressings in addition to standard prevention reduce PU incidence category 2 or worse compared to standard prevention alone. Methods: Multicentre, randomised controlled, medical device trial conducted in eight Belgian hospitals. At risk adult patients were centrally randomised (n=1633) to study groups based on a 1:1:1 allocation: experimental group 1 (n=542) and 2 (n=545) ‐ pooled as the treatment group ‐ and the control group (n=546). Experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on these body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU category 2 or worse at these body sites. Results: In the intention‐to‐treat population (n=1605); 4.0% of patients developed PUs category 2 or worse in the treatment group and 6.3% in the control group (RR=0.64, 95% CI 0.41 to 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 to 0.98, P=0.04). Heel PUs occurred in 1.4% and 1.9% of patients in the treatment and control group respectively (RR=0.76, 95% CI 0.34 to 1.68, P=0.49). Conclusions: Silicone foam dressings reduce the incidence of PUs category 2 or worse in hospitalised at‐risk patients when used in addition to standard of care. Results show a decrease for sacrum, but no statistical difference for heel/trochanter areas

Using a modified Delphi methodology to gain consensus on the use of dressings in chronic wounds management

Objective: Managing chronic wounds is associated with a burden to patients, caregivers, health services and society and there is a lack of clarity regarding the role of dressings in improving outcomes. This study aimed to provide understanding on a range of topics, including: the definition of chronicity in wounds, the burden of illness, clinical outcomes of reducing healing time and the impact of early interventions on clinical and economic outcomes and the role of matrix metalloproteinases (MMPs) in wound healing. Method: A systematic review of the literature was carried out on the role of dressings in diabetic foot ulcer (DFU), and venous leg ulcer (VLU) management strategies, their effectiveness, associated resource use/cost, and quality of life (QoL) impact on patients. From this evidence-base statements were written regarding chronicity in wounds, burden of illness, healing time, and the role of MMPs, early interventions and dressings. A modified Delphi methodology involving two iterations of email questionnaires followed by a face-to-face meeting was used to validate the statements, in order to arrive at a consensus for each. Clinical experts were selected, representing nurses, surgeons, podiatrists, academics, and policy experts. Results: In the first round, 38/47 statements reached or exceeded the consensus threshold of 80% and none were rejected. According to the protocol, any statement not confirmed or rejected had to be modified using the comments from participants and resubmitted. In the second round, 5/9 remaining statements were confirmed and none rejected, leaving 4 to discuss at the meeting. All final statements were confirmed with at least 80% consensus. Conclusion: This modified Delphi panel sought to gain clarity from clinical experts surrounding the use of dressings in the management of chronic wounds. A full consensus statement was developed to help clinicians and policy makers improve the management of patients with these conditions

Pressure ulcer risk assessment - registered nurses' experiences of using PURPOSE T : A focus group study

AIM: To evaluate the clinical usability of PURPOSE T among registered nurses in Sweden. BACKGROUND: Pressure ulcers are an adverse event and a problem worldwide. Risk assessment is a cornerstone, and a first step in pressure ulcer prevention is to identify possible risk patients and/or pressure ulcers. There are many pressure ulcer risk assessment instruments; however, they are not updated and/or evidence-based. PURPOSE T has been psychometrically evaluated in the UK and in Sweden with good inter-rater and test-retest reliability, and convergent validity was reported as moderate. DESIGN: A descriptive study design with a qualitative approach. METHODS: A total of six focus group interviews with 29 registered nurses were conducted. They were recruited from May 2018 to November 2018 from a university hospital and two nursing homes in Sweden. Data analysis was performed as described by Krueger. The study adheres to the COREQ guidelines. RESULTS: Four categories were identified: "An efficient risk assessment instrument performed at the bedside," "Deeper understanding and awareness of risk factors," "Benefits compared to the Modified Norton Scale" and "Necessity of integration of PURPOSE T in the electronic health record and team collaboration." CONCLUSION: The registered nurses acknowledged an overall positive perception of PURPOSE T´s clinical usability. Future research is needed to evaluate the feasibility of PURPOSE T. RELEVANCE TO CLINICAL PRACTICE: PURPOSE T has the potential to replace outdated pressure ulcers risk assessment instruments that are used today