Prophylactic dressing to minimise sacral pressure injuries in high risk hospitalised patients: A pilot study

Design: The study will use the CONSORT design to test feasibility outcomes over a 12 month period. All participants assessed as ‘high risk’ or greater of PI will be randomly assigned to either a ‘routine care group or dressings group’ . A total of 80 patients will be enrolled (40 per group) which is sufficiently large to yield estimates of effect size for the larger trial. Inclusion criteria: A least 18 years of age; able to provide written informed consent either in person or via guardian; assessed as ‘high risk’ or greater of PI (score of 15+ using the Waterlow Scale at admission); and expected hospital length of stay of at least 72hrs following recruitment. Exclusion criteria: suspected or actual spinal injury; lower back surgery (lumbar spine) which prevents the application of a sacral dressing; existing sacral PI, injury or allergy in the sacral area at the time of hospital admission; faecal incontinence at the time of hospital admission; unable to speak or understand English with no interpreter present. Recruitment: The Research Nurse (ResN) will screen general medical-surgical patients at specified admission entry points for eligibility into the study. If eligible, prospective participants or their guardian will be told about the study at an appropriate time during their admission and provided with sufficient time to read the information and consider their participation. Randomisation: Following consent, the ResN will contact an online randomisation service (based at Griffith University) to obtain a code for random allocation of participants to either the dressings group, or routine care only group. Randomisation will occur using a permuted block approach to ensure even distribution of participants’ diagnostic category (medical and surgical), using a 1:1 ratio with random variations in block sizes. On allocation to the dressings group, the ResN will apply a dressing to the participant’s sacrum, and document their dressing regime in the care plan/chart. Participants allocated to the routine care only group, will continue to receive usual care, as per hospital policy. Protocol fidelity: Education sessions will be conducted for nursing staff in the participating wards during in-service periods in January, 2014 prior to the commencement of trial (i.e., recruitment of participants in February, 2014). The frequency of these sessions will be dependent on the ward in-service schedule, but it is hoped that at least two x 30-60 minute sessions will be conducted in each participating ward area. These sessions will include information about the study, the dressing (including its application) and documentation using the data collection forms located in the end-of-bed charts. Nursing staff will also receive ongoing support by the PI/ResN during the trial period. Blind Assessors will be required to provide evidence of having undertaken pressure injury identification and assessment training using the NDNQI PI classification system and receive training by the PI regarding assessment and documentation using the Blind Assessor Case Report Form. During the study period, inter-rater assessment of 20 photos will be undertaken, by an additional with the expert assessor from being a blinded member of the Stomal Therapy and Wound Management Group. The PI will also provide training to the ResN via an orientation to the research protocol, procedures and data collection tools. Specific areas covered will include recruitment processes, daily data collection and inspection of the prophylactic sacral dressing. Both the ResN and Blind Assessor will also be required to sign a confidentiality agreement to formally recognise and accept their responsibility and obligations regarding the confidentiality of the information provided to them under the provision of the Public Health Act 2005. Regular meetings between the PI ResN and Blind Assessor will be arranged to provide support and ensure study fidelity. Regular random audits by the PI will evaluate the effectiveness of data management practices including the inter-rater reliability of assessment, the timely, accurate and consistent of data collection, and the correct entry of collected data into the electronic database. A trial specific education program will be provided to the ResN, blinded outcome assessors and nursing staff in the participating wards prior to the trial and include information about the study, the dressing and documentation using structured data collection forms. Random audits will be conducted to ensure correct inter-rater reliability of skin assessment and the timeliness, accuracy and consistency of data collection. Intervention: On allocation to the dressings group, the ResN will apply a self-adherent silicone foam bordered dressing to the patient’s sacrum, and document their dressing regime in the patient’s care plan/chart. Participants in the intervention arm will have the sacral dressing replaced every 3 days or sooner if loose or soiled. A number of nurse researchers undertaking quality improvement projects involving sacral foam dressings to prevent PI have reported changing the dressing every 3 days or twice a week safely and with good effect. Therefore this feasibility study will allow where possible, prophylactic silicone foam dressings to remain on intact skin for up to three days before replacement. Dressings will be applied until the participant is discharged from the ward or is mobilising independently. Where a PI is identified on a sacrum, the prophylactic dressing where clinically indicated, will be removed, and care processes actioned as per hospital policy. The dressing will also be removed in instances of skin reaction, faecal incontinence and patient-rated discomfort. Skin reaction will be reported via the incident reporting process and as an Adverse Event. All participants enrolled in both arms of the study will have their sacrum assessed daily by the ResN or RNs. Patients allocated to the routine care group, will continue to receive usual care, as per hospital policy. This consists of regular skin observation and nursing care via use of a pressure redistributing mattress, multi-disciplinary review (such as dietician and stomal therapy and wound management), and second hourly repositioning schedule. Blinding: As all members of the research team, nursing staff and participants will be aware of group allocation, only the outcome assessor(s) will be blinded. At each 72 hour point following admission, a high resolution digital photograph will be taken of each participant’s sacrum. De-identified and coded photographs will be saved to enable blind assessment in an area removed from the participating wards. Dressing: Mepilex (Registered Trademark) Border Sacrum dressings will be used as the prophylactic silicone foam dressing for this feasibility study. Mepilex (Registered Trademark) Border Sacrum dressings are specifically designed for the sacral area, are highly adaptable, comfortable and hypoallergenic. The silicone layer ensures that the dressing can be changed without damaging the wound or surrounding skin or exposing the patient to additional pain thereby minimising the risk for maceration. In addition to this, the dressing can be lifted and adjusted or removed and reapplied to allow for regular observation, without losing its adherent properties. The dressing is also moisture proof so can remain insitu during hygiene cares including showering and poses no risk for patient mobilisation. Advice from the manufacturer suggests the dressing can remain in place for several days when utilised for managing existing pressure injuries. Measures: Baseline characteristics of participants such as age, gender, place of and admission diagnosis, Waterlow score, existing PI (other than sacral), BMI, mobility and smoking status and health history. The primary measure (the presence and severity of sacral PI) will be assessed using PI staging classification systems. Secondary measures will include: 1) reasons for non-completion; 2) comfort, duration, dislodgement and removal of dressings; 3) suitability of recruitment site, time and budget allocation; 4) effectiveness of preparation sessions and level of support provided; 5) suitability of data collection tools; 6) inter-rater reliability, 7) data collection and management practices. Data collection: Recruitment processes will be recorded using the patient screening form. A Case Report Form (CRF) and end-of bed forms will collect data regarding assessment, dressing use, changes and comfort. Blind assessors will have their own CRF for the formal assessment of participant’s sacral area every 72 hours. Random audits will be conducted using a prepared checklist and staff will be evaluated using surveys post-intervention. Data analysis: All randomised participants will be analysed using an intention-to-treat approach as per their allocated group. The incidence and severity of PI will be measured as a categorical variable and proportions of PI in the two groups compared using Chi-squared. Cohen’s weighted kappa test will estimate inter-rate reliability. Logistic regression will be undertaken to estimate the odds ratio. Confidence intervals of 95% will be used for both groups. Secondary measures will be analysed using descriptive statistics. Ethics: This pilot trial will be conducted in accordance with the Helsinki declaration (2008), NHMRC and the National Statement Guidelines (2007) and will be registered with the Australian and New Zealand Trial Registry.