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Completed

NCT Number: NCT02690753

Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning

The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources.

The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed.

The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ St. Maarten, Duffel, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At risk of developing pressure ulcers (Braden score < 17)
  • Maximum 24hours admitted on the ward at the time of inclusion
  • Expected lenght of stay: 8 days
  • Free of pressure ulcers category II, II, IV and incontinence-associated dermatitis (IAD) category 2 at the start of the study

Exclusion criteria

  • Patients with no active or supportive therapy

Treatment and study plan

A protocol tailored to individual risk factors

Procedure

The Prevalon® Turn and Position System 2.0

Device

Comfort Shield® barrier cream cloths

Device

Primary outcomes

  1. Turning compliance of nurses within the trial period as assessed by the researcher (unannounced)

    Time frame: within 8 days after the start of the study

    The researcher wil collect and administer data about turning compliance and compliance with the protocol

Secondary outcomes

  1. Turning angle

    Time frame: within 8 days after the start of the study

    Per patient the researcher will measure two times the turning angle in which the patient is positioned.

  2. Sacrum free of pressure

    Time frame: within 8 days after the start of the study

    Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned.

  3. Incidence of pressure ulcers and incontinence-associated dermatitis

    Time frame: within 8 days after the start of the study

  4. Comfort and preferences of the caregiver

    Time frame: On baseline and at day 8 (the end of the study)

    Questions on comfort and preferences of the TAP, comfort shield barrier cream cloths and tailored repositioning will be assessed. At baseline these questions will assess the traditional care.

  5. Comfort and tolerance of the patient

    Time frame: At day 8 (the end of the study)

    Questions on comfort and tolerance of the TAP, comfort shield barrier cream cloths and repositioning will be assessed by the caregiver. At baseline these questions will assess the traditional care.

  6. Cost-effectiveness of the prevention of pressure ulcers

    Time frame: For the duration of the study (8 days)

    The following costs will be calculated to provide insight concerning cost-effectiveness:

    Objective time analysis of repositioning (by using a chronometer), Subjective time analysis of repositioning, Daily consumption of comfort shield barrier cream cloths and microclimate body pads

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Sage Products, LLC

Registry information

Official study title

A Turn and Positioning System and Standardized Incontinence Care Combined With Tailored Repositioning Versus a Standard Repositioning Protocol for Pressure Ulcer Prevention: A Multicenter Prospective Randomized Controlled Clinical Trial and Health Economical Analysis in a Hospital Setting

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2016
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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