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van CCT (UK)


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van CCT (UK)


Preventing surgical-site infections in primary total hip and total knee prostehesis.


- candidate number19351
- NTR NumberNTR4756
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2014
- Secondary IDsNL 32100.075.11 METC Isala
- Public TitlePreventing surgical-site infections in primary total hip and total knee prostehesis.
- Scientific TitleA peri-oparative mupirocin ointment en chlorhexidine bathing protocol decreases surgical site infections in knee and hip replacement
- ACRONYMMupirocine Prophylaxis Infection trial (MuPi trial)
- hypothesisMupirocin nasal ointment and chlorhexidine soap, reduces the risk of hospital-associated S. aureus infection in primary hip and knee replacement
- Healt Condition(s) or Problem(s) studiedTotal hip replacement, Total knee arthroplasty, Wound infection, Prevention
- Inclusion criteria- All patients have to be mentally competent
- Informed consent
- Age above 18
- Primary total hip replacement or primary total knee replacement
- Exclusion criteria- Not mentally competent
- Allergy for substances
- No previous hip or knee surgery before (arthroscopy is allowed)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jan-2019
- Target number of participants12000
- InterventionsThe intervention and control group starts five days before surgey with nasal ointment and bathing
- Primary outcomeReduction in surgical site infection
- Secondary outcomeDecolonization of S. aureus, swabs during surgery and before start intervention
- TimepointsInclusion will take three years in total, after inclusion follow-up will be one year. After four years all patients have enrolled the study with a minimal follow-up of one year
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES R. Rolink
- CONTACT for SCIENTIFIC QUERIES R. Rolink
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Achmea
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-aug-2014 - 19-sep-2014


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