Pressure sore risk in the operating department
| ISRCTN | ISRCTN43076542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43076542 |
| Protocol serial number | H23 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Miss Jane Bridal
Scientific
Scientific
-
-
-
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Surgery |
| Intervention | 1. Use of dry polymer gel pad on the operating table 2. Standard treatment |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Pressure sore incidence |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Key inclusion criteria | Patients who are over 55 years scheduled for elective major vascular, general and gynaecological surgery. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 08/01/1994 |
| Date of final enrolment | 30/04/1996 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
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-
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United Kingdom
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United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
