Do foam dressings prevent pressure sores?

This multi-site RCT will take place at three acute-care teaching public hospitals in South East Queensland. A consecutive sample of all eligible adult patients admitted to the participating medical-surgical wards who are assessed as at risk of developing a sacral hospital-acquired pressure injury (HAPI), will be invited to participate in the trial. Based on screening criteria, the ward Nurse Unit Manager or designate will mention the trial to the patient. If they agree to be approached, the Registered Nurse Research Assistant will then undertake the formal screening and consent patients. Participants allocated to the intervention group will receive a prophylactic silicone foam dressing (Mepliex Border Sacrum®) in addition to routine care according to the hospital procedures informed by state governance and international standards. The Registered Nurse Research Assistant (ResN) will take a baseline photograph of the participant’s sacrum and then apply the dressing. The dressing and sacral skin will be visually inspected by the ResN every day for up to 14 days, or until discharge or death, whichever occurs first. The dressing will be replaced as indicated by clinical practice (as per the manufacturer recommendations / instructions), and/or will be removed and replaced in instances where the dressing is not intact, rolled-up, soiled or saturated. In addition to the dressing being replaced in instances where the dressing is not intact, rolled-up, soiled or saturated, device deficiencies, as well as the possible causes, will be documented. Where there is evidence of skin irritation due to the dressing, the dressing will be removed, the skin reaction reported using standard hospital incident reporting protocols and the patient exited from the clinical study. Where the patient has developed persistent urinary and/or faecal incontinence, the sacral dressing will be removed, and the patient exited from the clinical study. The daily photograph of the sacrum will be sent to a blinded-to-intervention assessor for evaluation who will be trained in pressure injury staging in accordance with internationally recognised classification system. This classification is based on the depth of skin and tissue damage, from non-blanchable erythema (stage 1) to full thickness tissue loss (stage 4) and unstageable damage and suspected deep tissue injury. For each photograph where there is erythema present at the sacrum, the ResN will notify the outcome assessor as to whether the skin is blanching or non-blanching. The blinded outcome assessor will visually inspect the photographs daily for evidence of a sacral HAPI using standardised assessment method and notify the ResN and researchers of the result within the same day of receiving the photograph. Where a Stage 1 (i.e., non-balanceable erythema) is suspected by the ResN, the patient will be repositioned where possible, the site reassessed after 30 minutes and the photograph taken. If the patient is too unwell to undertake an assessment, the assessment on the day will be regarded as missing data. The patient will exit from the clinical study if it is determined that they have developed a sacral HAPI. If the patient has a sacral HAPI, then they will be included in the economic evaluation of treatment for follow-up for an additional 14 days (for a total of 28 days), or until discharge from hospital or death. Where there is no development of sacral HAPI, the patient will be followed-up for up to 14 days or until discharge from hospital or death. Where the treating nurse/clinician determines that the participant has a natal cleft HAPI, the participant will exit the study as PI treatment at the natal cleft may interfere with the intervention. A parallel process evaluation will also be undertaken. We will identify contextual factors and co-interventions related to clinical contexts, hospital procedures or individual clinical practice that may operate concurrently with the intervention. Fidelity will assess whether delivery of the intervention to participants as outlined in the study protocol, procedure manual, and training processes are consistent. Patient comfort and satisfaction with the dressing will enable assessment of intervention acceptability from participants’ perspective to enable refinements. We will also evaluate whether participants’ level of participation had any moderating effect on the results of the trial (as measured by the Patient Participation in Pressure Injury Prevention scale, a valid and reliable scale). Strategies for assessment and monitoring of adherence to content and coverage will include: • A standardized training program including presentations, practical training exercises and group reflection/discussion will be developed. • The program will include training resources including the Standard Operating Procedure (which will instructions of taking photographs of the sacrum, and advice on editing the image to ensure all photographs are similar – i.e., blurring the skin around the scarum to remove any sign of the dressing), Research Electronic Data Capture (REDCap) User Guide, Data Definition Dictionary, and script for recruitment • Training and subsequent assessment of inter-rater reliability of blinded-to-intervention outcome assessors to ensure assessment of sacral photographs will be based on international guidelines. Regular audits undertaken during the trial will monitor inter-rater reliability to indicate if additional training is required. • The use of REDCap for completion of the electronic Case Report Forms by the Registered Nurse Research Assistant (ResN) will include completion of screening, enrollment and allocation logs, baseline data collection and daily outcome assessment measures will be regularly monitored by the Clinical Trial Coordinator (CTC) / Chief Investigator (CI) to identify missing data, user-errors or any outstanding task. • Additional strategy for assessment and monitoring of adherence to content and coverage: Photography audits undertaken by the CTC and/or site investigators. Each audit will assess 10% of photographs at each site using the standardised Photography Audit Template, which will assess key aspects of photography including lighting, shadows, distance and angle, as well as photo modification. Strategies for adherence to frequency and duration (i.e. dose) will include: • Participant and staff perspectives (e.g. regarding difficulties / issues with the dressing) will be assessed via semi-structured interviews and focus groups, respectively, with data analysed thematically. • Outcome assessments for each participant recorded in REDCap will include daily patient satisfaction and comfort surveys, and other data relevant to the dose of the intervention (i.e. whether the trial dressing is insitu, how often the dressing is applied/changed/reapplied). This data will be regularly monitored by the CTC and CI. • Regular team and site meeting will be scheduled to monitor progress and manage issues as they arise. • ResN will be encouraged to document queries and concerns about aspects of the study including site-related issues via email to the CTC and CI and/or closed Yammer group, so all team members can read and respond to issues as they arise. The standardized training program will involve one 6-hour, trial-specific, face-to-face group training workshop conducted at one of the three sites and attended by all Registered Nurse Research Assistants. The workshop will be conducted 1 month to 2 weeks prior data collection commencing. Top up sessions will be conducted throughout the trial by Registered Nurses who are product specialists (as needed). The training program will cover the following content: • Overview of the trial, including background information, aims/objectives, methods and ethics. • Overview of data collection processes and timepoints (e.g. selection and withdrawal of participants, baseline data collection, daily outcome assessments, randomisation). • Intervention delivery, including specific training relevant to the use of the trial dressing and emphasis on importance of adherence/ fidelity. • The principals of Good Clinical Practice. • Safety reporting – definitions of AEs/SAEs and processes for reporting. • Using REDCap. • Standardised training is provided both face-to-face and virtually prior to and intermittently (e.g., to provide feedback on monthly photography audits) during the trial. The training will be administered by the researchers who are registered nurses or health professionals with clinical and research expertise relevant to wound care and conducting clinical trials. The training is provided both face-to-face and virtually (e.g., to accommodate for members of the research team working virtually).