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Emerging research evidence in the use of silicone dressings in the prevention of pressure injuries in critically ill and trauma patients
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Emerging research evidence in the use of silicone dressings in the prevention of pressure injuries in critically ill and trauma patients

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Nick Santamaria, Professor of Nursing Research, Translational Research University of Melbourne & Melbourne Health Royal Melbourne Hospital delivered this presentation at the Reducing Avoidable …

Nick Santamaria, Professor of Nursing Research, Translational Research University of Melbourne & Melbourne Health Royal Melbourne Hospital delivered this presentation at the Reducing Avoidable Pressure Injuries Conference. For more information about this annual event, please visit: www.healthcareconferences.com.au


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  • 1. Emerging research evidence in the use of silicone dressings in the prevention of pressure injuries in critically ill and trauma patients Professor Nick Santamaria University of Melbourne & Royal Melbourne Hospital
  • 2. Background • Pressure ulcer prevention in critically ill ICU patients is challenging with high incidence rates in some centres. • Hospital (ICU) acquired pressure injuries increase morbidity and may contribute to mortality in vulnerable individuals • Pressure ulcers increase costs, LOS and decrease bed availability • It is postulated that pressure injuries in ICU trauma patients may have originated in the Emergency Department (ED) and/or Operating Room (OR)
  • 3. Background • Hospital (ICU) acquired pressure injuries arise from the effects of pressure, shear and friction. • Microclimate is also postulated to contribute to pressure injuries (Call, 2011) • There is emerging evidence that some foam dressings may decrease pressure, shear and friction (Brindle et al 2010,2012) • There are no RCTs reported in the literature that investigate the effectiveness of these types of dressings in the ED/ICU patient
  • 4. Mechanisms of pressure injury in ICU Pressure, Friction & Shear
  • 5. How dressings Prevent Pressure Ulcers Pressure redistribution • Without a dressing •With a multi layer silicone foam dressing
  • 6. How dressings Prevent Pressure Ulcers Shear redistribution • Without a dressing •With a multi layer silicone foam dressing
  • 7. How dressings Prevent Pressure Ulcers Friction reduction • Without a dressing •With a multi layer silicone foam dressing
  • 8. How dressings Prevent Pressure Ulcers Balance of Microclimate • With a basic dressing •With a multi layer silicone foam dressing
  • 9. The Role of Dressings within the Prevention of Pressure Ulcers Consider the use of a multi layer silicone foam dressing to enhance, but not replace, pressure ulcer prevention strategies for the sacrum, buttocks and heel. (SOE = B) • Recent studies have indicated that multi layer soft silicone foam dressings applied to the sacral region help reduce pressure ulcer incidence. • Use of these dressings in addition to an appropriate pressure redistributing support surface may assist pressure ulcer prevention • Impact on the local microclimate between the skin, bed linen and the support surface. • It is essential to continue to provide routine pressure ulcer preventive care based on the level of risk for pressure ulcers
  • 10. The Role of Dressings within the Prevention of Pressure Ulcers Choose a dressing[s] that exceeds the area of tissue at risk on the sacrum, buttocks or heel to be protected from pressure and shear. (SOE=C) • Size the dressing to allow the pressure and shear forces to be deflected into tissue outside the area of risk. • The use of multiple dressings of the same type may be required to achieve this objective.
  • 11. The Role of Dressings within the Prevention of Pressure Ulcers Before selecting a dressing consider the current status of the skin and the ease of dressing removal in order to prevent mechanical stripping. (SOE= B) • Skin injury can result from repeated removal of strongly adhesive dressings. • If skin is torn, easily bruised or fragile use a dressing such as soft silicone which is recognised to prevent skin damage. • Consider the use of retention bandages carefully as incorrect application could lead to increased pressure upon the bony prominence.
  • 12. The Role of Dressings within the Prevention of Pressure Ulcers Protecting the sacrum and buttocks Consider placement of soft silicone dressings to the buttocks and sacrum when the head of the bed must be continuously elevated. (SOE = B) • Recent studies have indicated that multi layer soft silicone foam dressings applied to the sacral region help reduce pressure ulcer incidence. • When the head of bed is elevated, the pelvic region supports greater body mass therefore risking a potential increase in pressure and shear at the skin and soft tissues over the sacrum and buttocks.
  • 13. The Role of Dressings within the Prevention of Pressure Ulcers Protecting the heels Consider placement of multi layer soft silicone foam dressings to the heels prior to prolonged procedures or anticipated events when the patient cannot move or be moved from the supine position. (SOE=C) • The anatomy and physiology of the heel make the tissue very vulnerable to pressure. • When pressure is increased in high risk patients such as those with peripheral arterial disease and neuropathy, the risk of ulceration and failure to heal is greatly increased. • Patients at risk of increased pressure on the heel are those who cannot move their legs, such as patients who are anaesthetised, paralysed, or have undergone orthopaedic injury or surgery. These patients require additional precautions to prevent heel ulceration.
  • 14. The Role of Dressings within the Prevention of Pressure Ulcers Protecting the heels Consider placement of multi layer soft silicone foam dressings to the heels for patients at risk of shear injury. (SOE=C) • The anatomy and physiology of the heel make the tissue very vulnerable to friction and shear. • While pressure causes compression of the tissues, shear forces occur between the layers of the tissues, and tend to tear and separate them. • In some cases, this results in blister formation and breakdown of the fibres that tether the layers of fat and collagen together.
  • 15. The Role of Dressings within the Prevention of Pressure Ulcers Protecting the heels Select a multi layer silicone foam dressing that has been designed to conform to the heel or modify the dressing to fit the heel in accordance with the manufacturers’ recommendations. (SOE=C) • Dependent upon the position of the lower extremity, both the posterior and lateral aspects of the calcaneus are at risk for injury. • The multilayer silicone foam dressing must wrap around the calcaneus to provide posterior and bilateral protection, but not prevent the application of appropriate footwear or ambulation. • The anatomy, perfusion, shape and angle of the calcaneus all play a pivotal role in the development of pressure ulcers and may vary between patients.
  • 16. The Role of Dressings within the Prevention of Pressure Ulcers Continue to inspect the skin beneath the dressing on a regular basis in accordance with standards of care and/or institutional policy. (SOE = C) • Dressing selection should encompass the ability of the dressing to be removed to allow skin inspection on a regular basis. This will be dependent on the atraumatic nature of the dressing.
  • 17. The Border Trial A prospective randomised controlled trial of the effectiveness of absorbent soft silicone self adherent dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill ED/ICU patients. • Professor Nick Santamaria, University of Melbourne & Royal Melbourne Hospital • A/Professor Keryln Carville, Curtin University & Silver Chain • Dr Jenny Prentice, WoundsWest & Health Department of Western Australia • A/Professor Marie Gertz, Melbourne Health & University of Melbourne • Professor Elizabeth Manias, University of Melbourne • Sarah Sage, Clinical Nurse Consultant Wound Care, Royal Park Hospital • Amy Freeman , Podiatrist, Royal Melbourne Hospital • Jane McCann, Podiatrist, Royal Park Campus • Theresa Vassiliou, Research Nurse ED, Royal Melbourne Hospital • Stephanie De Vincentis, Clinical Nurse Consultant Wound Care, Royal Melbourne Hospital • Ai Wei Ng, Clinical Nurse Consultant Wound Care, Royal Park Hospital • A/Professor Jonathan Knott, Deputy Director Emergency Department, Royal Melbourne Hospital & University of Melbourne
  • 18. Royal Melbourne Hospital Intensive Care Unit
  • 19. Aim • To investigate the clinical efficacy of the use of Mepilex Border Sacrum and Heel dressings in preventing pressure injuries in critically ill ICU patients when applied in the Emergency Department.
  • 20. Hypothesis Patients treated with Mepilex Border Sacrum and Mepilex Heel dressings will have a lower incidence rate of sacral and heel pressure injury development than patients receiving standard care.
  • 21. Methods Design Prospective randomised controlled open label trial Subjects and Sampling All trauma and critically ill patients admitted to the Emergency Dept and to be transferred to ICU
  • 22. Methods Primary endpoint • Incidence rates of pressure injuries in ICU expressed as the total number of pressure injuries developed in both groups Secondary endpoint • Cost of trial dressings to prevent pressure injuries • Cost of the management of developed pressure injuries
  • 23. Methods Sample size Calculated to detect a decrease in the ICU pressure injury incidence rate of 3.5% (from 4% to 0.5%) in the intervention group with power set at 80% and alpha of 0.05 Total of 440 patients (220 patients per group). First patient enrolled April 28 2011
  • 24. Methods Inclusion criteria ED and ICU admission for critical illness and/or major trauma Over 18 years old Exclusion criteria Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure injury Trauma to sacral and/or heel area
  • 25. Intervention: Mölnlycke Border Sacrum dressing applied on admission to the Emergency Department and inspected daily and changed every 3 days in ICU
  • 26. Intervention: Mölnlycke Mepilex Heel dressings and retained with Tubifast applied on admission to ED, inspected daily and changed every 3 days in ICU
  • 27. Measurement Patient demographics Age Wt Gender Pre-existing disease Reason for admission and diagnosis Management pre admission Eg. Time on spinal board Time in Ambulance Time in ED ED management – ventilation ED physiological observations Time in OR Time in ICU Braden score Immobility
  • 28. Measurement: Sacrum and heels examined daily for duration of ICU stay or until endpoint reached. Pressure ulcers: Pressure injury incidence Pressure injuries will be staged according to the Australian Wound Management Association (AWMA) staging Cost of trial dressings used for total duration of trial Cost of management of developed pressure injuries Staff time Consumables Physiological data All physiological data collected in ICU Shock/SIRS Cardiac arrest Drive lines Mechanical ventilation Pharmaceutical data All drugs Sedation/Paralytics Vasopressor drugs
  • 29. Methods Ethics • Approved by Melbourne Health Human Research Ethics Committee 2011 • University of Melbourne Human Research Ethics Committee 2011 Registration Clinical Trial Notification Scheme (CTN 2011) Aust Clinicaltrials.com (US) Funding Mölnlycke Health Care
  • 30. Results – Patient characteristics on admission to ED n=301 Control N=151 Intervention N=150 p Age (mean) 55 53 NS Sex (M/F) 92/48 88/51 NS MAP (mmHg) 94 94 NS Pulse (mean) 96 97 NS Respiratory rate (mean) 16.8 17.9 NS O2 Sat % 98 97 NS Braden score (median) 9 8 NS
  • 31. Results – Pressure Injuries n=301 Pressure injury development Control N=151 Intervention N=150 p Time to first pressure injury (mean days) 3.2 5.7 0.07 Patients who developed PI 15 3 0.005 Number of pressure injuries 22 5 0.001 Sacral pressure injuries 6 1 0.11 Heel pressure injuries 17 4 0.006 Pressure injury incidence 15.2% 3.3% 0.05
  • 32. Interim conclusions • Intervention and control groups were comparable on key demographics on Emergency Dept admission and enrollment into the trial • The intervention (dressings) group had significantly different outcomes to controls: – Less patients with a pressure injury – Less pressure injuries in total – Took longer to develop an injury – Lower PI incidence rate • Mepilex dressings appear to confer a degree of protection against ICU acquired sacral and heel PI when applied in ED • Results should be interpreted with caution as trial is ongoing
  • 33. Consensus Statement Global Evidence Based Practice Recommendations for the Use of Wound Dressings to Augment Pressure Ulcer Prevention Protocols August 2012