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WithdrawnNCT03148821Updated Nov 7, 2023

Pressure Area Distribution on a Variety of Clinical Surfaces

An observational study in Pressure Ulcer, sponsored by Brighton and Sussex University Hospitals NHS Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Brighton and Sussex University Hospitals NHS Trust · Observational

Why this study was withdrawn
Loss of promised funding
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pressure Ulcer

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Keywords

  • pressure ulcer
  • pressure sore
  • patient positioning
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

Browse Pressure Ulcer studies →

Lead sponsor

Brighton and Sussex University Hospitals NHS Trust is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • Inability to provide informed written consent
  • Having a 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 take part.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: 125 minutes

Secondary outcomes

  1. 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.

    Time frame: 125 minutes

07

Study locations

1 site
  • Brighton and Sussex University Hospitals NHS Trust
    Brighton, East Sussex TN62DS, United Kingdom
08

References and documents

Publications

  • 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. PubMed 15082426 ↗
  • 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. PubMed 25874704 ↗
  • 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. PubMed 22886290 ↗
  • 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. PubMed 22104042 ↗
  • 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.

Individual participant data

Plan to share: Yes — The authors plan to disseminate the findings of this study by publishing in the academic literature.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03148821
Lead sponsor
Brighton and Sussex University Hospitals NHS Trust
Responsible party
Sponsor
First posted
May 11, 2017
Start date
Jul 1, 2017
Primary completion
Oct 2018 (estimated)
Completion
Oct 2018 (estimated)
Last update
Nov 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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