What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?

NCT05142878 | Completed

• 1 other identifier: EC/2020/BC-06758
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 5

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. They occur frequently among patients with limited mobility, such as those patients being bed-bound and/or wheelchair-bound. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for healthcare. International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. All interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. As pressure ulcers can arise in a number of ways, interventions for prevention and treatment need to be applied across a wide range of settings, including the community, nursing homes and hospitals. A review of mortality and severe harm incidents reported to the National Reporting and Learning System found that pressure ulcers were the largest proportion of patient safety incidents in 2011/2012, accounting for 19% of all reports. 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 analysing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis. Continuous low levels or short-term high levels of pressure and shear on the skin and underlying tissue on vulnerable areas are extrinsic factors contributing to the development of pressure ulcers. Support surfaces (e.g. any mattresses, integrated bed systems, mattress replacement, overlay, seat cushion, or seat cushion overlay) are specialized devices for pressure redistribution specifically designed for management of tissue loads, micro- climate, and/or therapeutic functions. A Cochrane systematic review by McInnes et al. (2015) defined multiple groups of pressure redistribution materials: low-tech (not electrically driven) constant low-pressure supports, high-tech supported surfaces, and other supported surfaces (operating table mattress pad, rotating beds, cushions, and limb protectors). 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 (2016) found a pressure ulcer incidence of 5.1% in patients placed on static air support surfaces (mattress overlay, heel wedge, and seat cushion) in a high risk population in a nursing home setting in Belgium. A multicentre randomised controlled clinical trial in 26 nursing homes (including 308 residents) between April 2017 and May 2018 resulted in a significantly lower pressure ulcer incidence when applying the principle of static air (n=8/154, 5.2%) compared to the alternating air group (n=18/154, 11.7%)(p=0.04). The median time to develop a pressure ulcer category II-IV was significantly longer in the static air group (10.5 days, IQR 1-14) compared to the alternating air group (5.4 days, IQR 1-12; p=0.05). The study concluded that a static air mattress was significantly more effective compared to an alternating air pressure mattress to prevent pressure ulcers in a high risk nursing home population. This multicentre cohort study will be performed in 5 nursing homes in a random sample of 40 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.

Conditions

Pressure Ulcer; Pressure Injury; Pressure Sore; Bed Sore

Keywords

static air support devices; High risk population; Elderly; Prevention; Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• Pressure ulcer incidence (Cat. II+)

  Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices

  14 days

Secondary Outcomes (1)

• Insight in caretakers' experiences and perceptions

  14 days

Study Arms (1)

Experimental: Static air support devices (Ultracore Repose®)

EXPERIMENTAL

Residents will be placed on a static air foam hybrid mattress during 14 days: • Ultracore Repose® Mattress

Device: Ultracore Repose® mattress

Interventions

Ultracore Repose® mattress DEVICE

Residents will be placed on the Ultracore Repose® mattress during 14 days

Experimental: Static air support devices (Ultracore Repose®)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• High risk of pressure ulcers (Braden score \< 12) and/or pressure ulcer category 1,
• Bedbound (\> 8 hours in bed) or chair bound (\> 8 hours in chair),
• Aged \> 65 years,

You may not qualify if:

• Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer,
• Expected length of stay \< 2 weeks,
• End of life care,
• Medical contraindication for use of static air support devices
• Caretakers:
• Caretakers will be included in the focus group interviews if they have experience with the use of both the Ultracore Repose® mattress and the Repose overlay mattress®

Sponsors & Collaborators

• University Ghent: lead
• Frontier Medical Group, UK: collaborator

Study Sites (5)

WZC Egmont

Zottegem, Oost-Vlaanderen, Belgium

Location

WZC Heilig Hart

Oudenaarde, Osst-Vlaanderen, Belgium

Location

Woonzorgcentrum Ter Potterie

Bruges, West-Vlaanderen, Belgium

Location

Huize Zonnelied

Ieper, West-Vlaanderen, Belgium

Location

De Plataan

Izegem, West-Vlaanderen, Belgium

Location

Related Links

• Description Website of the research group

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dimitri Beeckman

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 3, 2021
• Study Start: July 15, 2020
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)