Clinical trial NCT03725787: Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
Official title: Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Pressure Injury
Pressure Sore
Bed Sore
Keywords: Static air support surface
Support device
Elderly
Prevention
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Care of Sweden
First posted: 2018-10-31
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.

It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.

Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium.

The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.


Eligibility criteria: Inclusion Criteria:

* At risk of pressure ulcer development based on a Braden score ≤ 17
* Bedbound or chair bound
* Aged ≥ 65

Exclusion Criteria:

* Short-stay residents (expected length of stay ≤14 days)
* End of life care
* Medical contraindication for patient repositioning/turning
* Pressure ulcer Cat. II+ present on initial evaluation

Primary outcomes:
measure: Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
timeFrame: 30 days
Secondary outcomes:
measure: Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)
timeFrame: 30 days
measure: Comfort of participants (self developed questionnaire)
timeFrame: 30 days
Other outcomes:
Locations:
city: Deinze
country: Belgium
facility: WZC Sint-Vincentius
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: WZC Sint-Jozef
state: Oost-Vlaanderen
city: Kaprijke
country: Belgium
facility: WZC Sint-Vincentius
state: Oost-Vlaanderen
city: Mariakerke
country: Belgium
facility: WZC Brugse Vaart
state: Oost-Vlaanderen
city: Merelbeke
country: Belgium
facility: Provinciaal Zorgcentrum Lemberge
state: Oost-Vlaanderen
city: Ursel
country: Belgium
facility: WZC Onderdale
state: Oost-Vlaanderen
city: Wondelgem
country: Belgium
facility: Residentie Vroonstalle
state: Oost-Vlaanderen
city: Liedekerke
country: Belgium
facility: WZC Sint-Rafaël
state: Vlaams-Brabant
Study officials:
affiliation: Study Principal Investigator
name: Dimitri Beeckman, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 201.
citation: Levy A, Kopplin K; BS; Gefen A. Computer simulations of efficacy of air-cell-based cushions in protecting against reoccurrence of pressure ulcers. J Rehabil Res Dev. 2014;51(8):1297-319. doi: 10.1682/JRRD.2014.02.0048.
citation: Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. doi: 10.1186/s13063-016-1703-8.