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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial

Authors: Holly Wong, Jaime Kaufman, Barry Baylis, John M. Conly, David B. Hogan, Henry T. Stelfox, Danielle A. Southern, William A. Ghali, Chester H. Ho

Published in: Trials | Issue 1/2015

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Abstract

Background

Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers.

Methods/Design

A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups’ interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge).

Discussion

This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers.

Trials registration

ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).
Literature
1.
Woodbury MG, Houghton PE. Prevalence of pressure ulcers in Canadian healthcare settings. Ostomy Wound Manage. 2004;50:22–39.PubMed
2.
Redelings MD, Lee NE, Sorvillo F. Pressure ulcers: more lethal than we thought? Adv Skin Wound Care. 2005;18:367–72.CrossRefPubMed
3.
4.
Assadian O, Oswald JS, Leisten R, Hinz P, Daeschlein G, Kramer A. Management of leg and pressure ulcer in hospitalized patients: direct costs are lower than expected. GMS Krankenhaushygiene interdisziplinär. 2011; 6 Doc07. doi: 10.​3205/​dgkh000164.
5.
Graves N, Birrell FA, Whitby M. Modeling the economic losses from pressure ulcers among hospitalized patients in Australia. Wound Repair Regen. 2005;13:462–7.CrossRefPubMed
6.
Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care. 2012;21:261–6.CrossRefPubMed
7.
Brem H, Maggi J, Nierman D, Rolnitzky L, Bell D, Rennert R, et al. High cost of stage IV pressure ulcers. Am J Surg. 2010;200:473–7.
8.
Chan BC, Nanwa N, Mittmann N, Bryant D, Coyte PC, Houghton PE. The average cost of pressure ulcer management in a community dwelling spinal cord injury population. Int Wound J. 2013;10:431–40.CrossRefPubMed
9.
Brito PA, Generoso SV, Correia MITD. Prevalence of pressure ulcers in hospitals in Brazil and association with nutritional status - A multicenter, cross-sectional study. Nutrition. 2013;29:646–9.CrossRefPubMed
10.
Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, et al. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013;50:974–1003.
11.
Dorner B, Posthauer ME, Thomas D. The role of nutrition in pressure ulcer prevention and treatment: National Pressure Ulcer Advisory Panel white paper. Adv Skin Wound Care. 2009;22:212–21.CrossRefPubMed
12.
Cox J. Predictors of pressure ulcers in adult critical care patients. Am J Crit Care. 2011;20:364–75.CrossRefPubMed
13.
Marin J, Nixon J, Gorecki C. A systematic review of risk factors for the development and recurrence of pressure ulcers in people with spinal cord injuries. Spinal Cord. 2013;51:522–7.CrossRefPubMed
14.
Allen V, Ryan D, Lomax N, Murray A. Accuracy of interface pressure measurement systems. J Biomed Eng. 1993;15:344–8.CrossRefPubMed
15.
Sprigle S, Sonenblum S. Assessing evidence supporting redistribution of pressure for pressure ulcer prevention: a review. J Rehabil Res Dev. 2011;48:203–13.CrossRefPubMed
16.
Dharmarajan T, Ugalino J. Pressure ulcers: clinical features and management. Hosp Physician. 2002;38:64–71.
17.
Hanson DS, Langemo D, Anderson J, Thompson P, Hunter S. Can pressure mapping prevent ulcers? Nursing2013. 2009;39:50–1.CrossRef
18.
Landis EM. Micro-injection studies of capillary blood pressure in human skin. Heart. 1930;15:209–28.
19.
Peterson MJ, Schwab W, Van Oostrom JH, Gravenstein N, Caruso LJ. Effects of turning on skin‐bed interface pressures in healthy adults. J Adv Nurs. 2010;66:1556–64.CrossRefPubMed
20.
Ryan D, Byrne P. A study of contact pressure points in specialised beds. Clin Phys Physiol Meas. 1989;10:331.CrossRefPubMed
21.
Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev. 2014;4:CD009958.PubMed
22.
Moore ZE, Cowman S. Repositioning for treating pressure ulcers. Cochrane Database Syst Rev. 2009;2:CD006898.PubMed
23.
Black JM, Edsberg LE, Baharestani MM, Langemo D, Goldberg M, McNichol L, et al. Pressure ulcers: avoidable or unavoidable? Results of the national pressure ulcer advisory panel consensus conference. Ostomy Wound Manage. 2011;57:24.
24.
Niederhauser A, Lukas CV, Parker V, Ayello EA, Zulkowski K, Berlowitz D. Comprehensive programs for preventing pressure ulcers: a review of the literature. Adv Skin Wound Care. 2012;25:167–88.CrossRefPubMed
25.
Guidelines CfSCMCP. Pressure ulcer prevention and treatment following spinal cord injury: a clinical practice guideline for health-care professionals. J spinal cord med. 2001;24:S40.CrossRef
26.
Bergstrom N, Braden BJ, Laguzza A, Holman V. The Braden scale for predicting pressure sore risk. Nurs Res. 1987;36:205–10.
27.
Pancorbo‐Hidalgo PL, Garcia‐Fernandez FP, Lopez‐Medina IM, Alvarez‐Nieto C. Risk assessment scales for pressure ulcer prevention: a systematic review. J Adv Nurs. 2006;54:94–110.CrossRefPubMed
28.
Scott RG, Thurman KM. Visual Feedback of Continuous Bedside Pressure Mapping to Optimize Effective Patient Repositioning. Adv Wound Care. 2014;3:376–82.CrossRef
29.
Shapcott N, Levy B. By the numbers: Making the case for clinical use of pressure measurement mat technology to prevent the development of pressure ulcers. Team Rehab Report. 1999;16–9.
30.
Stinson MD, Porter-Armstrong A, Eakin P. Pressure mapping systems: reliability of pressure map interpretation. Clin Rehabil. 2003;17:504–11.CrossRefPubMed
31.
Behrendt R, Ghaznavi AM, Mahan M, Craft S, Siddiqui A. Continuous bedside pressure mapping and rates of hospital-associated pressure ulcers in a medical intensive care unit. Am J Crit Care. 2014;23:127–33.CrossRefPubMed
32.
Siddiqui A, Behrendt R, Lafluer M, Craft S. A continuous bedside pressure mapping system for prevention of pressure ulcer development in the medical ICU: a retrospective analysis. Wounds. 2013;25:333–9.PubMed
33.
Motamedi S, de Grood J, Harman S, Sargious P, Baylis B, Felmons W, et al. The effect of continuous pressure monitoring on strategic shifting of medical inpatients at risk for PUs. J Wound Care. 2012;21(11):517–27.
34.
Black J1, Baharestani M, Cuddigan J, Dorner B, Edsberg L, Langemo, D et al. National Pressure Ulcer Advisory Panel's updated pressure ulcer staging system. Dermatol Nurs. 2007;19(4):343-9. quiz 350.
35.
36.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377–81.CrossRefPubMed
37.
Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336:601–5.
Metadata
Title
Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial
Authors
Holly Wong
Jaime Kaufman
Barry Baylis
John M. Conly
David B. Hogan
Henry T. Stelfox
Danielle A. Southern
William A. Ghali
Chester H. Ho
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0949-x

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