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NCT ID: NCT06369688 Not yet recruiting - Pressure Ulcer Clinical Trials

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

IdealSkinCares
Start date: October 1, 2025
Phase: N/A
Study type: Interventional

The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.

NCT ID: NCT05142878 Completed - Pressure Ulcer Clinical Trials

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

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03725787 Completed - Pressure Ulcer Clinical Trials

Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

Start date: March 4, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03597750 Completed - Pressure Ulcer Clinical Trials

Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers

Start date: April 19, 2017
Phase: N/A
Study type: Interventional

Maintaining and improving skin health are major goals in acute and long-term care. Patients at the extremes of age, the critically ill, medically compromised and those with immobility are at risk for developing several skin disorders, with pressure ulcers (PUs) as one of the most common and mostly preventable ones. Prevalence figures of PUs vary between 6.4% and 31.4%. PUs are described as localised injuries to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure combined with shear. Prevention of PUs is internationally seen to be a key quality indicator of care. To prevent PUs, reducing both the amount and the duration of pressure and shear at the pressure points of the body is strongly recommended. One of the interventions to achieving this, is the use of pressure-reducing devices (mattresses, cushions, etc.). Studies that compare the (cost-) effectiveness of different pressure-reducing devices are needed. The primary aim of this study is to compare the (cost-) effectiveness of pressure ulcer prevention in high risk patients using static air support devices (Repose®) versus alternating-pressure devices. The second aim is to get insight in patients' experiences and perceptions of comfort using static air support devices and alternating-pressure devices. The third aim is to get insight in caretakers' perceptions of barriers and facilitators of the use of static air support devices and alternating-pressure devices and to reveal how these perceptions influence the readiness to use the products in clinical practice. This randomized controlled trial will be performed in ca. 25 nursing homes in a random sample of 306 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.

NCT ID: NCT03391310 Completed - Pressure Ulcer Clinical Trials

Use of Honey for Pressure Ulcers in Critically Ill Children

Start date: September 2, 2017
Phase: N/A
Study type: Interventional

The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure and new onset infection of ulcer.

NCT ID: NCT02705443 Recruiting - Pressure Ulcer Clinical Trials

Early Identification of Suspected Deep Tissue Injury (sDTI)

Start date: February 2016
Phase: N/A
Study type: Observational

The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.