Condition category
Surgery
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
25/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Jane Bridal

ORCID ID

Contact details

-
-
-
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H23

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Surgery

Intervention

1. Use of dry polymer gel pad on the operating table
2. Standard treatment

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Pressure sore incidence

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/01/1994

Overall trial end date

30/04/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are over 55 years scheduled for elective major vascular, general and gynaecological surgery.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

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

Trial participating centre

-
-
-
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1998 results in: http://www.ncbi.nlm.nih.gov/pubmed/9801935

Publication citations

  1. Results

    Nixon J, McElvenny D, Mason S, Brown J, Bond S, A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores., Int J Nurs Stud, 1998, 35, 4, 193-203.

Additional files

Editorial Notes