Osteoarthritis, KneeNCT05972603
Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty
A study testing 1.0 g Vancomycin powder into the wound and 0,35% povidone-iodine solution lavage in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Independent Public Healthcare Center in Rypin at 1 site in Poland.
Trial summary
The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Rheumatoid Arthritis
- What is being tested?
- 1.0 g Vancomycin powder into the wound and 0,35% povidone-iodine solution lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing THA or TKA as a result of osteoarthritis or rheumatoid arthritis, can understand and comply with the study protocol, have signed the informed consent document at screening
Who cannot join
- Patients referred to the hospital in order to undergo THA or TKA due to different reason than osteoarthritis, rheumatoid arthritis or avascular necrosis of the femoral head, such as: failed femoral neck fractures, displaced acetabular fractures or revision acetabular fractures, revision knee or hip arthroplasty
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
IPHC Rypin
Rypin, Kujawsko-pomorksie, 87-500
Karol Elster, Md Phd, +48662128773, karol.elster@gmail.com
About this study
Official title: Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial
The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted povidone-iodine (PI) protocol.
Read the detailed description
Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation.
Patients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder into the wound around the prosthesis and no suction will be used.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Rheumatoid Arthritis, Avascular Necrosis of Hip
- Being tested
- 1.0 g Vancomycin powder into the wound, 0,35% povidone-iodine solution lavage
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.0 g Vancomycin powder into the woundProcedure or surgery
0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound
0,35% povidone-iodine solution lavageProcedure or surgery
0,35% povidone-iodine solution lavage left for 3 minutes following final implantation
| Study group | Role | What they receive |
|---|---|---|
| 0,35% povidone-iodine solution lavage | Experimental | 0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation. Receives: Procedure: 0,35% povidone-iodine solution lavage |
| 1.0 g Vancomycin powder into the wound | Experimental | additional 1.0 g Vancomycin powder into the wound Receives: Procedure: 1.0 g Vancomycin powder into the wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
periprosthetic joint infection
infection rate in each group
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Jul 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Independent Public Healthcare Center in Rypin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972603
- Sponsor's protocol ID
- 1234
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kulakowski M, Elster K, Szymczak M, Sleczka P, Baumgart M, Krolikowska A, Reichert P. Comparison of the effect of combined usage of povidone-iodine irrigation and topical vancomycin powder to the use of povidone-iodine irrigation alone on the periprosthetic joint infection incidence rate in patients undergoing primary total hip and knee arthroplasty: a protocol for multicenter prospective randomized clinical trial. Trials. 2024 Jul 10;25(1):468. doi: 10.1186/s13063-024-08306-3.
PubMed 38987786
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05972603
- Acronym / sponsor ID
- 1234
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Rheumatoid Arthritis, Avascular Necrosis of Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Independent Public Healthcare Center in RypinUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted povidone-iodine (PI) protocol.
Detailed description
Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation.
Patients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder into the wound around the prosthesis and no suction will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0,35% povidone-iodine solution lavage | Experimental | Procedure: 0,35% povidone-iodine solution lavage0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation. |
| 1.0 g Vancomycin powder into the wound | Experimental | Procedure: 1.0 g Vancomycin powder into the woundadditional 1.0 g Vancomycin powder into the wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing THA or TKA as a result of osteoarthritis or rheumatoid arthritis, can understand and comply with the study protocol, have signed the informed consent document at screening
Key exclusion criteria (1 listed)
- Patients referred to the hospital in order to undergo THA or TKA due to different reason than osteoarthritis, rheumatoid arthritis or avascular necrosis of the femoral head, such as: failed femoral neck fractures, displaced acetabular fractures or revision acetabular fractures, revision knee or hip arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.0 g Vancomycin powder into the wound0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound | Procedure or surgery | 1.0 g Vancomycin powder into the wound |
| 0,35% povidone-iodine solution lavage0,35% povidone-iodine solution lavage left for 3 minutes following final implantation | Procedure or surgery | 0,35% povidone-iodine solution lavage |
Primary outcome
periprosthetic joint infection
Time frame: 90 days
infection rate in each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Derived from this study: PubMed 38987786Kulakowski M, Elster K, Szymczak M, Sleczka P, Baumgart M, Krolikowska A, Reichert P. Comparison of the effect of combined usage of povidone-iodine irrigation and topical vancomycin powder to the use of povidone-iodine irrigation alone on the periprosthetic joint infection incidence rate in patients undergoing primary total hip and knee arthroplasty: a protocol for multicenter prospective randomized clinical trial. Trials. 2024 Jul 10;25(1):468. doi: 10.1186/s13063-024-08306-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.0 g Vancomycin powder into the wound and 0,35% povidone-iodine solution lavage in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Independent Public Healthcare Center in Rypin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periprosthetic joint infection (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05972603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.