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
Protocol serial number N0202133839
Sponsor Department of Health
Funder Royal Cornwall Hospitals NHS Trust (UK)
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

Primary study designInterventional
Study designDouble-blind randomised controlled trial
Secondary study designRandomised controlled trial
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
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Chlorhexidine acetate
Primary outcome measure(s)

Excess of 50 ml blood loss in chlorhexidine acetate group will be considered significant.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration130
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

  • United Kingdom
  • England

Study participating centre

Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom

Results and Publications

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