Clinical trial • Not applicable • Infectious Disease | Musculoskeletal
VANCOMYCIN for Total joint replacement (hip or knee)
Not applicable trial of VANCOMYCIN for Total joint replacement (hip or knee).
Overview
- Trial Therapeutic Area
- Infectious Disease | Musculoskeletal
- Trial Disease
- Total joint replacement (hip or knee)
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-06-2024
- First CTIS Authorization Date
- 08-10-2024
Trial design
Randomised, open-label, arms compare irrigation solutions and local antibiotic: povidone-iodine irrigation (0.35% pi) versus normal saline irrigation; chlorhexidine irrigation (0.05%) versus normal saline irrigation; local vancomycin (topical/local vancomycin, product record lists max total amount 2 g) versus no local vancomycin. (arms are described as combinations of lavage type with/without local vancomycin.)-controlled Not applicable trial across 13 sites in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arms compare irrigation solutions and local antibiotic: Povidone-iodine irrigation (0.35% PI) versus normal saline irrigation; Chlorhexidine irrigation (0.05%) versus normal saline irrigation; local vancomycin (topical/local vancomycin, product record lists max total amount 2 g) versus no local vancomycin. (Arms are described as combinations of lavage type with/without local vancomycin.)
- Target Sample Size
- 325
- Trial Duration For Participant
- 365
Eligibility
Recruits 325 No vulnerable population selected. Informed consent is required; 'Did not provide informed consent.' is listed as an exclusion. No assent or minor-specific procedures are indicated in the record..
- Vulnerable Population
- No vulnerable population selected. Informed consent is required; 'Did not provide informed consent.' is listed as an exclusion. No assent or minor-specific procedures are indicated in the record.
Inclusion criteria
- {"criterion_text":"- Patients 18 years of age or older."}
- {"criterion_text":"- Undergoing primary or aseptic revision TJR"}
Exclusion criteria
- {"criterion_text":"- Received antibiotics for any reason in the two weeks prior to their TJR."}
- {"criterion_text":"- Prior enrollment in the trial including the pilot study."}
- {"criterion_text":"- Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial."}
- {"criterion_text":"- A contraindication to study interventions."}
- {"criterion_text":"- Chronic or acute infection at or near the TJR site."}
- {"criterion_text":"- Prior history of periprosthetic joint infection including any reoperation due to infection."}
- {"criterion_text":"- Undergoing surgery for a diagnosis of a fracture."}
- {"criterion_text":"- Open infected wounds on affected limb"}
- {"criterion_text":"- Undergoing bilateral TJR."}
- {"criterion_text":"- Currently enrolled in a study that does not permit co-enrollment"}
- {"criterion_text":"- Did not provide informed consent."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome is infection that requires reoperation within 12 months of TJR.","definition_or_measurement_approach":"Reoperation due to infection within 12 months of primary or aseptic revision hip or knee total joint replacement; measured as occurrence of infection requiring reoperation within 12 months."}
Recruitment
- Planned Sample Size
- 325
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent required from adult participants (18 years and older). 'Did not provide informed consent.' is listed as an exclusion. Subject information and informed consent form documents are available in Spanish (e.g. 'L1_SIS and ICF_Annex 1_Spanish_clean', 'L1_SIS and ICF General_Spanish_clean'). No assent procedures or minor consent documents are indicated.
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 325
Spain
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 657
- Number Of Sites
- 13
- Number Of Participants
- 325
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Pablo Sanz Ruiz
- Principal Investigator Email
- psanzr@salud.madrid.org
- Contact Person Name
- Pablo Sanz Ruiz
- Contact Person Email
- psanzr@salud.madrid.org
- Site Name
- Hospital Universitario Principe De Asturias
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Ana Castel Oñate
- Principal Investigator Email
- ana.castel@salud.madrid.org
- Contact Person Name
- Ana Castel Oñate
- Contact Person Email
- ana.castel@salud.madrid.org
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Ricardo Larrainzar Garijo
- Principal Investigator Email
- Ricardo.larrainzar@salud.madrid.org
- Contact Person Name
- Ricardo Larrainzar Garijo
- Contact Person Email
- Ricardo.larrainzar@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Orthopedic Surgery and Traumatology Service (Hip Unit)
- Principal Investigator Name
- María Mercedes Reverté
- Principal Investigator Email
- mariamercedes.reverte@vallhebron.cat
- Contact Person Name
- María Mercedes Reverté
- Contact Person Email
- mariamercedes.reverte@vallhebron.cat
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Orthopedic Surgery and Traumatology Service (Hip Unit)
- Principal Investigator Name
- Ernesto Muñoz
- Principal Investigator Email
- e.munoz.mahamud@gmail.com
- Contact Person Name
- Ernesto Muñoz
- Contact Person Email
- e.munoz.mahamud@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Juan Carlos Martinez
- Principal Investigator Email
- Jcmartin@clinic.cat
- Contact Person Name
- Juan Carlos Martinez
- Contact Person Email
- Jcmartin@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Ernesto Guerra
- Principal Investigator Email
- ernestomelchor.guerra@vallhebron.cat
- Contact Person Name
- Ernesto Guerra
- Contact Person Email
- ernestomelchor.guerra@vallhebron.cat
- Site Name
- Parc Sanitari Sant Joan De Deu
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Sara Castellanos Alonso
- Principal Investigator Email
- sara.castellanos@sjd.es
- Contact Person Name
- Sara Castellanos Alonso
- Contact Person Email
- sara.castellanos@sjd.es
- Site Name
- Consorci Sanitari De Terrassa
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Javier Alonso Rodríguez Piedra
- Principal Investigator Email
- 8846@cst.cat
- Contact Person Name
- Javier Alonso Rodríguez Piedra
- Contact Person Email
- 8846@cst.cat
- Site Name
- Consorci Sanitari De L'Alt Penedes I Garraf
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Alfred Dealbert
- Principal Investigator Email
- adealbert@csapg.cat
- Contact Person Name
- Alfred Dealbert
- Contact Person Email
- adealbert@csapg.cat
- Site Name
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Margarita Veloso Duran
- Principal Investigator Email
- mveloso@mutuaterrassa.es
- Contact Person Name
- Margarita Veloso Duran
- Contact Person Email
- mveloso@mutuaterrassa.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Eduardo García Rey
- Principal Investigator Email
- egrey@salud.madrid.org
- Contact Person Name
- Eduardo García Rey
- Contact Person Email
- egrey@salud.madrid.org
- Site Name
- Hospital San Juan De Dios Santurtzi
- Department Name
- Orthopedic Surgery and Traumatology Service (Knee Unit)
- Principal Investigator Name
- Jesús Moreta
- Principal Investigator Email
- ospitaleasanturtzi.vconsultas@sjd.es
- Contact Person Name
- Jesús Moreta
- Contact Person Email
- ospitaleasanturtzi.vconsultas@sjd.es
Sponsor
Primary sponsor
- Full Name
- Hamilton Health Sciences Corporation
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Canada
Investigational products
- Investigational Product Name
- VANCOMYCIN
- Active Substance
- VANCOMYCIN
- Modality
- Small molecule
- Routes Of Administration
- CUTANEOUS USE
- Route
- CUTANEOUS USE
- Authorisation Status
- 2
- Maximum Dose
- 2 g
- Investigational Product Name
- CHLORHEXIDINE
- Active Substance
- BENZALKONIUM CHLORIDE; CHLORHEXIDINE GLUCONATE; BENZYL ALCOHOL
- Modality
- Small molecule
- Routes Of Administration
- CUTANEOUS USE
- Route
- CUTANEOUS USE
- Authorisation Status
- 2
- Starting Dose
- 0.05% (W/V) percent weight/volume
- Maximum Dose
- 0.05% (W/V)
- Investigational Product Name
- POVIDONE
- Active Substance
- POVIDONE
- Modality
- Small molecule
- Routes Of Administration
- CUTANEOUS USE
- Route
- CUTANEOUS USE
- Authorisation Status
- 2
- Starting Dose
- 0.35% percent
- Maximum Dose
- 0.35%
- Investigational Product Name
- Normal saline
- Modality
- Small molecule
- Routes Of Administration
- CUTANEOUS USE
- Route
- CUTANEOUS USE
- Authorisation Status
- 2
- Starting Dose
- 0.9% (W/V) percent weight/volume
- Maximum Dose
- 0.9% (W/V)
- Combination Treatment
- Yes
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