Comparison of blood loss following the use of chlorhexidine acetate to saline for lavage during primary total knee replacement

ISRCTN ISRCTN42907199
DOI https://doi.org/10.1186/ISRCTN42907199
Secondary identifying numbers N0202133839
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
17/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M Divekar
Scientific

Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom

Phone +44 (0)1872 253960
Email abc@email.com

Study information

Study designDouble-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleComparison of blood loss following the use of chlorhexidine acetate to saline for lavage during primary total knee replacement
Study objectivesIs there an increase (statistically significant) in blood loss following use of chlorhexidine acetate to lavage the knee in total knee replacement?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Knee arthroplasty
Intervention130 volunteers will have saline or chlorhexidine acetate used to lavage and blood loss estimated at 48 hours.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Chlorhexidine acetate
Primary outcome measureExcess of 50 ml blood loss in chlorhexidine acetate group will be considered significant.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/2003
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants130
Key inclusion criteria130 patients
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/07/2003
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Cornwall Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan