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Randomized Controlled Trial
. 2023 Nov;20(9):3567-3579.
doi: 10.1111/iwj.14230. Epub 2023 Jun 9.

Clinical and cost effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for the prevention of hospital-acquired pressure injuries. A randomised controlled trial

Suzanne Kapp  1 , Marie Gerdtz  1 , Amit Gefen  2 , William Padula  3   4 , Paulo Alves  5 , Chenel Trevellini  6 , Angaj Ghosh  7 , Ashley Shea  8 , Anthony Cross  8 , Ines Sousa  1 , Nick Santamaria  1
Affiliations
Randomized Controlled Trial

Clinical and cost effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for the prevention of hospital-acquired pressure injuries. A randomised controlled trial

Suzanne Kapp et al. Int Wound J. 2023 Nov.

Abstract

Pressure injuries affect 13.1% to 45.5% of patients in the intensive care unit and lead to pain and discomfort for patients, burden on healthcare providers, and unnecessary cost to the health system. Turning and positioning systems offer improvements on usual care devices, however the evidence of the effectiveness of such systems is still emerging. We conducted an investigator initiated, prospective, single centre, two group, non-blinded, randomised controlled trial to determine the effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for preventing PIs. The trial was prematurely discontinued after enrolment of 78 participants due to COVID-19 pandemic related challenges and lower than expected enrolment rate. The study groups were comparable on baseline characteristics and adherence to the interventions was high. Four participants developed a PI (in the sacral, ischial tuberosity or buttock region), n = 2 each in the intervention and control group. Each participant developed one PI. As the trial is underpowered, these findings do not provide an indication of the clinical effectiveness of the interventions. There was no participant drop-out or withdrawal and there were no adverse events, device deficiencies, or adverse device effects identified or reported. The results of our study (in particular those pertaining to enrolment, intervention adherence and safety) provide considerations for future trials that seek to investigate how to prevent PIs among ICU patients.

Keywords: intensive care unit; pressure injury; pressure ulcer; prevention; randomised controlled trial.

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Conflict of interest statement

Suzanne Kapp has received research funds for investigator‐initiated studies and has been invited by Mölnlycke Health Care to speak at conferences and symposia. Nick Santamaria and Amit Gefen are consultants to Mölnlycke Health Care and members of its Global Pressure Ulcer/Injury Advisory Board, and have received research funds from Mölnlycke. Mölnlycke has not controlled (or regulated) the research carried out by Nick Santamaria and Amit Gefen. William Padula declares Personal Fees and Equity Holdings with Monument Analytics, LLC.

Figures

FIGURE 1
FIGURE 1
Usual care turning and positioning devices.
FIGURE 2
FIGURE 2
Intervention turning and positioning system.
FIGURE 3
FIGURE 3
CONSORT flow‐chart.
See this image and copyright information in PMC

References

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    1. Clinical Excellence Commission . 2018, 2017 NSW Pressure Injury Point Prevalence Survey Report (2018), Sydney: Clinical Excellence Commission. 2018.
    1. Padula B, Chen Y, Santamaria N. Five‐layer border dressings as part of a quality improvement bundle to prevent pressure injuries in US skilled nursing facilities and Australian nursing homes: a cost‐effectiveness analysis. Int Wound J. 2019;16(6):1263‐1272. - PMC - PubMed

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