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
Scientific
Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom
| Phone | +44 (0)1872 253960 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Comparison of blood loss following the use of chlorhexidine acetate to saline for lavage during primary total knee replacement |
| Study objectives | Is 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) studied | Surgery: Knee arthroplasty |
| Intervention | 130 volunteers will have saline or chlorhexidine acetate used to lavage and blood loss estimated at 48 hours. |
| Intervention type | Drug |
| Phase | Not 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 date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 130 |
| Key inclusion criteria | 130 patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom
TR1 3LJ
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 |