Pressure Area Distribution on a Variety of Clinical Surfaces

Pressure Ulcer Clinical Trial

Official title:

Pressure Area Distribution on a Variety of Clinical Surfaces in a Group of 51 Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03148821
• Other study ID #: 169214
• Status: Withdrawn
• Start date: July 1, 2017
• Est. completion date: October 2018

Study information

• Verified date: November 2023
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. Ambulance scoop: supine (lying flat on their back)

2. A&E trolley: supine

3. Hospital bed: supine

4. Theatre table: supine

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).

Each participant will remain in each position on that particular surface for a period of 25 minutes. A pressure mapping mattress will lie between the participant and the surface assessed to generate a pressure map.

Following completion of data collection, data will be analysed and any areas of potential pressure damage vulnerability will be identified.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Pressure Ulcer

Locations

Country	Name	City	State
United Kingdom	Brighton and Sussex University Hospitals NHS Trust	Brighton	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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).

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

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. — View 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: Perth, Australia; 2014.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PRESSURE AREA DISTRIBUTION ON A VARIETY OF CLINICAL SURFACES IN A GROUP OF 51 VOLUNTEERS	Gain information to allow calculation of a sample size for a definitive study.	125 minutes