The effect of systematic warming (Pegasus-Inditherm mattress) on outcomes of elective major surgery

ISRCTN ISRCTN24335828
DOI https://doi.org/10.1186/ISRCTN24335828
Protocol serial number N0159121895
Sponsor Department of Health (UK)
Funder North Tees and Hartlepool NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
18/02/2010
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

Prof David J Leaper
Scientific

North Tees & Hartlepool NHS Trust
Professorial Unit of Surgery
North Tees General Hospital
Stockton-on-Tees
TS19 8PE
United Kingdom

Phone +44 (0)1642 624162
Email david.leaper@nth.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesDoes patient warming reduce perioperative and post-operative complications?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Perioperative and post-operative complications
InterventionWarming matress switched on or off.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Post-operative complications including pressure ulcers, infection, length of hospital stay, time to mobilisation.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration320
Key inclusion criteriaPatients (n=320) undergoing major elective surgery (general, gynaecological, orthopaedic).
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2002
Date of final enrolment31/08/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

North Tees & Hartlepool NHS Trust
Stockton-on-Tees
TS19 8PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2007 Yes No