Pressure Area Distribution on a Variety of Clinical Surfaces

NCT03148821 | Withdrawn

• 1 other identifier: 169214
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Participants in the study will be adults with full mobility, with the capacity to give informed written consent. The investigators will recruit a group of volunteers in order to represent a variety of BMIs, in an attempt to gain a sample of the BMIs found in the population. The investigators will mimic current practices and standard equipment in order to replicate real conditions as closely as possible. Participants will lay on the following surfaces in the following scenarios

1. 1.Ambulance scoop: supine (lying flat on their back)
2. 2.A\&E trolley: supine
3. 3.Hospital bed: supine
4. 4.Theatre table: supine
5. 5.Theatre table: Left lateral (lying on their left side at 90 degrees to the operating table) with pelvic binders (pads designed to keep the hip immobile).

Conditions

Pressure Ulcer

Keywords

pressure ulcer; pressure sore; patient positioning

Outcome Measures

Primary Outcomes (1)

• PRESSURE AREA DISTRIBUTION ON A VARIETY OF CLINICAL SURFACES IN A GROUP OF 51 VOLUNTEERS

  Establish the pressure distributions of current patient surfaces in use, for a variety of different sized patients, to identify any points in the patient's journey when they are at risk of developing pressure damage.

  125 minutes

Secondary Outcomes (1)

• PRESSURE AREA DISTRIBUTION ON A VARIETY OF CLINICAL SURFACES IN A GROUP OF 51 VOLUNTEERS

  125 minutes

Study Arms (1)

Healthy volunteer participants

The investigators propose a snap shot study in a group of healthy volunteers of varying BMIs, laying on surfaces a patient would be exposed to during their hospital stay. Participants will lie on a variety of surfaces they may find themselves on during an emergency admission to hospital, including an operating table, in a variety of positions. Participants pressure distributions in each scenario will be measured with a pressure sensing mattress.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in the study will be adults with full mobility, with the capacity to give informed written consent. We will recruit a group of volunteers in order represent a variety of BMIs, in an attempt to gain a sample of the BMIs found in the population.

You may qualify if:

• Subjects will be individuals aged 18 and over, with good command of spoken and written English, full mobility, and the capacity to give informed, written consent. Provided there is no impairment to mobility, there is no upper age limit to participation.

You may not qualify if:

• Inability to provide informed written consent
• Having a BMI that falls outside of the stated ranges for the study (\<19)
• Any significant impairment to mobility, for whatever reason, that prevents the patient from getting in and out of bed unaided, walking 100 metres unaided, or climbing a flight of stairs unaided.
• Patients who lack sufficient command of written and spoken English to allow them to give written informed consent take part.

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead

Study Sites (1)

Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, TN62DS, United Kingdom

Location

Related Publications (7)

• Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086.

  PMID: 15082426 BACKGROUND

• Chen HL, Chen XY, Wu J. The incidence of pressure ulcers in surgical patients of the last 5 years: a systematic review. Wounds. 2012 Sep;24(9):234-41.

  PMID: 25874704 BACKGROUND

• Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care. 2012 Jun;21(6):261-2, 264, 266. doi: 10.12968/jowc.2012.21.6.261.

  PMID: 22886290 BACKGROUND

• DOWNIE F, GUY H, GILROY P, ROYALL D, DAVIES S. Are 95% of hospital-acquired pressure ulcers avoidable?. Wounds UK. 2013 Sep 1;9(3).

  BACKGROUND

• Hibbs P. The economic benefits of a prevention plan for pressure sores. In4th National Pressure Sore Symposium, Bath 1988 Apr (Vol. 20).

  BACKGROUND

• McInnes E, Jammali-Blasi A, Bell-Syer S, Dumville J, Cullum N. Preventing pressure ulcers--Are pressure-redistributing support surfaces effective? A Cochrane systematic review and meta-analysis. Int J Nurs Stud. 2012 Mar;49(3):345-59. doi: 10.1016/j.ijnurstu.2011.10.014. Epub 2011 Nov 20.

  PMID: 22104042 BACKGROUND

• 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: Perth, Australia; 2014.

  BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: May 11, 2017
• Study Start: July 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)