Pressure sore risk in the operating department

ISRCTN	ISRCTN43076542
DOI	https://doi.org/10.1186/ISRCTN43076542
Secondary identifying numbers	H23

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 25/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Miss Jane Bridal
Scientific

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-
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United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study hypothesis	A comprehensive review of the literature reveals little information relating to the genesis of intra-operative pressure sores, and the contribution of operating room practice on aetiology is undefined. In an attempt to examine this area of clinical practice and answer the general question - is pressure sore prevention in the operating department possible? - a randomised trial of the 'standard' operating table mattress versus a dry polymer gel pad, involving patients who are over 55 years scheduled for elective major vascular, general and gynaecological surgery is proposed. Specific research questions include: 1. What are the benefits of using a dry polymer gel pad on the operating table in relation to intra-operative pressure sore incidence? 2. Which key variables are associated with intra-operative pressure sore development? 3. What is the extent of pre-operative pressure damage to skin? Expected findings are speculative since little data is available. However, it is anticipated that a 75% lower incidence of intra-operative pressure sores will be observed in the treatment group (gel pad) when compared to the control ('standard') and that a preoperative prevalence of 10-30% is recorded. Potential benefits to the NHS include informed use of the dry polymer gel pad, cost savings associated with the prevention of pressure sores, and an improved ability to predict those at risk intraoperatively allowing more efficient targeting of preventative interventions. With regard to preoperative pressure sore development, the results will provide an indication of the scope of the problem.
Ethics approval(s)	Not provided at time of registration
Condition	Surgery
Intervention	1. Use of dry polymer gel pad on the operating table 2. Standard treatment
Intervention type	Procedure/Surgery
Primary outcome measure	Pressure sore incidence
Secondary outcome measures	Not provided at time of registration
Overall study start date	08/01/1994
Overall study end date	30/04/1996

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Participant inclusion criteria	Patients who are over 55 years scheduled for elective major vascular, general and gynaecological surgery.
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	08/01/1994
Recruitment end date	30/04/1996

Locations

Countries of recruitment

United Kingdom

Study participating centre

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United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/1998		Yes	No