Periprosthetic Joint InfectionPhase 3PREVENT-ITNCT05084378
Evaluation of Emerging New Treatments for Infection Prevention in Total Joint Replacement
A Phase 3 study testing Povidone-Iodine Lavage Solution, Chlorhexidine Lavage Solution and Topical Antibiotic in people with Periprosthetic Joint Infection and Draining Wound, run by McMaster University at 6 sites in 2 countries.
Trial summary
At the end of total joint replacement (TJR) surgery, surgeons wash and clean the surgical wound. This is done to lower the risk of infections. Currently, most surgeons use saline to wash the surgical wound and do not place antibiotics in the wound . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection, Draining Wound
- What is being tested?
- Povidone-Iodine Lavage Solution, Chlorhexidine Lavage Solution and Topical Antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 11 Mar 2022to 28 Oct 2024
- Phase
- Phase 3
- 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
- Patients 18 years of age or older.
- Undergoing primary or revision TJR.
- Informed consent obtained.
Who cannot join
- Received antibiotics for any reason in the two weeks prior to their TJR.
- Chronic or acute infection at or near the TJR site.
- Prior history of PJI.
- Undergoing surgery for a diagnosis of a fracture.
- Open wounds on affected limb.
- Undergoing bilateral TJR.
Show all 16Show fewer
- Medical contraindication to povidone-iodine.
- Medical contraindication to chlorhexidine.
- Medical contraindication to vancomycin.
- Current or anticipated incarceration.
- Terminal illness with expected survival less than 90 days.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Prior enrollment in the trial.
- Other reason to exclude the patient, as approved by the Methods Centre.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada4 sites
St. Joseph's Healthcare
Hamilton, Ontario, L8N4A6
Hamilton Health Sciences- Juravinkski Hospital
Hamilton, Ontario, L8V 1C3
Montreal General Hospital
Montreal, Quebec
St. Mary's Hospital
Montreal, Quebec
Spain2 sites
Hospital Clinic Barcelona
Barcelona
Vall d'Hebron University Hospital
Barcelona
About this study
Official title: Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement: A Pilot Study
At the end of total joint replacement (TJR) surgery, surgeons wash and clean the surgical wound. This is done to lower the risk of infections. Currently, most surgeons use saline to wash the surgical wound and do not place antibiotics in the wound . However, some recent studies have shown that using povidone-iodine and chlorhexidine-based solutions (both are types of antiseptics) to wash the surgical site and placing antibiotics directly into the wound may be effective in reducing infections in TJR surgery compared to saline and no antibiotics. However, no study has determined which solution is better at reducing the number of infections in patients undergoing TJR. The investigators also do not know if the addition of antibiotics applied to the wound will decrease infections. Currently, there are no surgical guidelines around infection prevention in total joint replacement. A large scale, multi-site, pragmatic 3 x 2 factorial randomized controlled trial is need that compares these six treatment groups. However, before this, a smaller pilot study must be conducted to determine the feasibility of a larger study. PREVENT-iT will address these important gaps in knowledge and clinical practice.
Read the detailed description
The investigators propose a pilot study that will determine the feasibility of a definitive trial that compares irrigation fluids and topical antimicrobials to reduce the risk of wound complications requiring reoperation in patients undergoing primary or aseptic revision hip or knee TJR.
In the pilot phase, the investigators will compare three irrigation fluids (povidone-iodine lavage, chlorohexidine lavage, and normal saline) and the investigators will compare the use of vancomycin powder versus no powder in a 3 x 2 factorial RCT design.
Therefore, eligible and consenting participants will be randomized to one of six treatment groups:
- Povidone-iodine lavage and local antibiotics
- Chlorhexidine lavage and local antibiotics
- Normal saline lavage and local antibiotics
- Povidone-iodine lavage with no local antibiotics
- Chlorhexidine lavage with no local antibiotics
- Normal saline lavage with no local antibiotics
Study participants will be assessed at regular intervals in the one year following their TJR. The primary clinical outcome is PWD or PJI requiring reoperation within 90 days of TJR. The secondary clinical outcome is PJI within 12 months of TJR.
The time frame of 90 days was selected for the primary clinical endpoint (any reoperation for PWD or PJI) for the pilot phase of this study because the interventions may have a profound impact within the first three months after TJR. Measuring the primary outcomes at this time will allow the study team to examine any acute and early outcomes related to the intervention. This will also provide the study team with the opportunity to identify any potential problems with the interventions.
The one-year timeframe for the secondary clinical endpoint (PJI) was selected for the pilot phase of this study because the majority of PJIs are likely to be diagnosed with one year of TJR surgery. This time frame will allow the study team to record and analyze most of the PJIs, and like the primary outcomes, it will allow for the examination of early outcomes, and any potential problems with the treatments.
The investigators hypothesize the following:
- Patients who have their surgical wound irrigated with either povidone-iodine or chlorhexidine will have a significantly lower rate of PWD and PJI requiring reoperation compared to patients who have their wound irrigated with saline.
- Patients who have their surgical wound irrigated with povidone-iodine will have similar rates of PWD and PJI requiring reoperation as compared to patients treated with chlorohexidine.
- Patients who receive topical vancomycin will have a significantly lower rate of PWD and PJI requiring reoperation compared to patients who did not receive topical antibiotics.
- Patients who have their surgical wound irrigated with either povidone-iodine or chlorhexidine will have a significantly lower rate of PJI compared to patients who have their wound irrigated with saline.
- Patients who have their surgical wound irrigated with povidone-iodine will have similar rates of PJI compared to patients treated with chlorohexidine.
- Patients who receive topical vancomycin will have a significantly lower rate of PJIs compared to patients who did not receive topical antibiotics.
Participants will be followed for one year for safety and in anticipation that the pilot study may continue into the definitive trial phase. At the conclusion of the pilot study, the Principal Investigators will determine whether to:
- Continue with the existing protocol and proceed with the definitive trial.
- Revise the protocol based on lessons learned from the pilot phase.
- Conclude that the trial is not feasible.
The feasibility objectives in our pilot study do not lend themselves to traditional quantitative sample size calculations. The sample size for the pilot study will be 500 patients. This sample size for the pilot study was chosen in consideration of the following items:
- Due to the low event rate of PJI/PWD in this population, our initial sample size estimates suggest that the investigators will need a sample size of approximately 20,000 patients for the definitive trial. Given the large size of the definitive trial, a larger than usual sample size of 500 participants is needed and will represent approximately 2.5% of the sample size of a definitive trial. This will provide sufficient data to inform feasibility, sample size, and refine the design of the proposed definitive trial.
- As the definitive trial will have a large sample size and will be international in scale, the investigators need to demonstrate to our potential funding agencies our ability to enroll a high number of patients and maintain high level data collection and follow-up.
- The investigators also require a sufficient number of events in the pilot study to establish the adjudication process. A sample size of 500 participants will allow for the reporting and adjudication of approximately 15 events.
Statistical Methods:
Analysis Plan Overview The analysis and reporting of results will follow the CONSORT guidelines for reporting of randomized pilot and feasibility trials. The investigators will use descriptive statistics, reported as count and percentage or mean and standard deviation depending on the type of variable to summarize the results of our feasibility objectives of this pilot study. Feasibility outcomes will be based on descriptive statistics reported as % (95% CI).
The analyses will be conducted using R (Vienna, Austria).
- Conditions
- Periprosthetic Joint Infection, Draining Wound
- Being tested
- Povidone-Iodine Lavage Solution, Chlorhexidine Lavage Solution, Topical Antibiotic, Saline Lavage Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-Iodine Lavage SolutionDrug
0.35% povidone-iodine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.35% povidone-iodine and sterile isotonic saline solution may also be used.
Chlorhexidine Lavage SolutionDrug
0.05% chlorhexidine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.05% chlorhexidine and sterile isotonic saline may also be used.
Topical AntibioticDrug
2 grams Vancomycin powder
Saline Lavage SolutionDrug
1 litre of sterile isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Povidone-iodine Lavage and Local Antibiotics | Experimental | 1 litre of 0.35% povidone-iodine lavage solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure. Receives: Drug: Povidone-Iodine Lavage Solution; Drug: Topical Antibiotic |
| Chlorhexidine Lavage and Local Antibiotics | Experimental | 1 litre of 0.05% chlorhexidine lavage solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure. Receives: Drug: Chlorhexidine Lavage Solution; Drug: Topical Antibiotic |
| Normal Saline Lavage and Local Antibiotics | Experimental | 1 litre of sterile isotonic saline solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure. Receives: Drug: Topical Antibiotic; Drug: Saline Lavage Solution |
| Povidone-iodine Lavage Solution with no Local Antibiotics | Experimental | 1 litre of 0.35% povidone-iodine lavage solution will be used immediately prior to closure. Receives: Drug: Povidone-Iodine Lavage Solution |
| Chlorhexidine Lavage Solution with no Local Antibiotics | Experimental | 1 litre of 0.05% chlorhexidine lavage solution will be used immediately prior to closure. Receives: Drug: Chlorhexidine Lavage Solution |
| Normal Saline Lavage with no Local Antibiotics | Active comparator | 1 litre of sterile isotonic saline solution will be used immediately prior to closure. Receives: Drug: Saline Lavage Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a Definitive Trial based on the following criteria domains: 1) Participant Enrollment, 2) Administration of Treatments, 3) Data Collection Methods, and 4)Compliance with the Protocol.
Each domain will be interpreted via a "traffic light" approach, in which "green" will indicate moving forward as is with the definitive trial, "yellow" will mean proceeding with some modifications, and "red" will indicate that the definitive trial is not feasible. Feasibility criteria will be monitored over the course of the pilot study and modifications will be made to the protocol during the pilot phase to increase feasibility.
Measured: 2 - 2.5 years
Secondary outcomes (1)
Persistent Wound Drainage (PWD) and Periprosthetic Joint Infections (PJI) requiring reoperation
Incidence of PWD and PJI events requiring reoperation will be measured. PWD will be defined as a non-infectious disturbance in wound healing of short duration that occurs during the days following TJR. PJI will be defined by the Musculoskeletal Infection Society (MSIS) criteria for diagnosis of PJI. Reoperations will include, but are not limited to, irrigation, debridement, liner exchange, and implant exchange. Reoperations for hardware complications or fracture will not be considered study events. A blinded Adjudication Committee will review all reported reoperations to confirm that they meet the criteria for being a study event.
Measured: Within 90 days of the Total Joint Replacement Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start11 Mar 2022
- Primary completion4 Aug 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Wood, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084378
- Sponsor's protocol ID
- PREVENT-IT
- Acronym
- PREVENT-IT
- Status last verified
- May 2025
- First submitted
- 22 Aug 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement: A Pilot Study
- ClinicalTrials.gov ID
- NCT05084378
- Acronym / sponsor ID
- PREVENT-IT / PREVENT-IT
- Conditions
- Periprosthetic Joint Infection, Draining Wound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 4 Aug 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 19 Oct 2021 (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.
At the end of total joint replacement (TJR) surgery, surgeons wash and clean the surgical wound. This is done to lower the risk of infections. Currently, most surgeons use saline to wash the surgical wound and do not place antibiotics in the wound . However, some recent studies have shown that using povidone-iodine and chlorhexidine-based solutions (both are types of antiseptics) to wash the surgical site and placing antibiotics directly into the wound may be effective in reducing infections in TJR surgery compared to saline and no antibiotics. However, no study has determined which solution is better at reducing the number of infections in patients undergoing TJR. The investigators also do not know if the addition of antibiotics applied to the wound will decrease infections. Currently, there are no surgical guidelines around infection prevention in total joint replacement. A large scale, multi-site, pragmatic 3 x 2 factorial randomized controlled trial is need that compares these six treatment groups. However, before this, a smaller pilot study must be conducted to determine the feasibility of a larger study. PREVENT-iT will address these important gaps in knowledge and clinical practice.
Detailed description
The investigators propose a pilot study that will determine the feasibility of a definitive trial that compares irrigation fluids and topical antimicrobials to reduce the risk of wound complications requiring reoperation in patients undergoing primary or aseptic revision hip or knee TJR.
In the pilot phase, the investigators will compare three irrigation fluids (povidone-iodine lavage, chlorohexidine lavage, and normal saline) and the investigators will compare the use of vancomycin powder versus no powder in a 3 x 2 factorial RCT design.
Therefore, eligible and consenting participants will be randomized to one of six treatment groups:
- Povidone-iodine lavage and local antibiotics
- Chlorhexidine lavage and local antibiotics
- Normal saline lavage and local antibiotics
- Povidone-iodine lavage with no local antibiotics
- Chlorhexidine lavage with no local antibiotics
- Normal saline lavage with no local antibiotics
Study participants will be assessed at regular intervals in the one year following their TJR. The primary clinical outcome is PWD or PJI requiring reoperation within 90 days of TJR. The secondary clinical outcome is PJI within 12 months of TJR.
The time frame of 90 days was selected for the primary clinical endpoint (any reoperation for PWD or PJI) for the pilot phase of this study because the interventions may have a profound impact within the first three months after TJR. Measuring the primary outcomes at this time will allow the study team to examine any acute and early outcomes related to the intervention. This will also provide the study team with the opportunity to identify any potential problems with the interventions.
The one-year timeframe for the secondary clinical endpoint (PJI) was selected for the pilot phase of this study because the majority of PJIs are likely to be diagnosed with one year of TJR surgery. This time frame will allow the study team to record and analyze most of the PJIs, and like the primary outcomes, it will allow for the examination of early outcomes, and any potential problems with the treatments.
The investigators hypothesize the following:
- Patients who have their surgical wound irrigated with either povidone-iodine or chlorhexidine will have a significantly lower rate of PWD and PJI requiring reoperation compared to patients who have their wound irrigated with saline.
- Patients who have their surgical wound irrigated with povidone-iodine will have similar rates of PWD and PJI requiring reoperation as compared to patients treated with chlorohexidine.
- Patients who receive topical vancomycin will have a significantly lower rate of PWD and PJI requiring reoperation compared to patients who did not receive topical antibiotics.
- Patients who have their surgical wound irrigated with either povidone-iodine or chlorhexidine will have a significantly lower rate of PJI compared to patients who have their wound irrigated with saline.
- Patients who have their surgical wound irrigated with povidone-iodine will have similar rates of PJI compared to patients treated with chlorohexidine.
- Patients who receive topical vancomycin will have a significantly lower rate of PJIs compared to patients who did not receive topical antibiotics.
Participants will be followed for one year for safety and in anticipation that the pilot study may continue into the definitive trial phase. At the conclusion of the pilot study, the Principal Investigators will determine whether to:
- Continue with the existing protocol and proceed with the definitive trial.
- Revise the protocol based on lessons learned from the pilot phase.
- Conclude that the trial is not feasible.
The feasibility objectives in our pilot study do not lend themselves to traditional quantitative sample size calculations. The sample size for the pilot study will be 500 patients. This sample size for the pilot study was chosen in consideration of the following items:
- Due to the low event rate of PJI/PWD in this population, our initial sample size estimates suggest that the investigators will need a sample size of approximately 20,000 patients for the definitive trial. Given the large size of the definitive trial, a larger than usual sample size of 500 participants is needed and will represent approximately 2.5% of the sample size of a definitive trial. This will provide sufficient data to inform feasibility, sample size, and refine the design of the proposed definitive trial.
- As the definitive trial will have a large sample size and will be international in scale, the investigators need to demonstrate to our potential funding agencies our ability to enroll a high number of patients and maintain high level data collection and follow-up.
- The investigators also require a sufficient number of events in the pilot study to establish the adjudication process. A sample size of 500 participants will allow for the reporting and adjudication of approximately 15 events.
Statistical Methods:
Analysis Plan Overview The analysis and reporting of results will follow the CONSORT guidelines for reporting of randomized pilot and feasibility trials. The investigators will use descriptive statistics, reported as count and percentage or mean and standard deviation depending on the type of variable to summarize the results of our feasibility objectives of this pilot study. Feasibility outcomes will be based on descriptive statistics reported as % (95% CI).
The analyses will be conducted using R (Vienna, Austria).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Povidone-iodine Lavage and Local Antibiotics | Experimental | Drug: Povidone-Iodine Lavage Solution, Drug: Topical Antibiotic1 litre of 0.35% povidone-iodine lavage solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure. |
| Chlorhexidine Lavage and Local Antibiotics | Experimental | Drug: Chlorhexidine Lavage Solution, Drug: Topical Antibiotic1 litre of 0.05% chlorhexidine lavage solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure. |
| Normal Saline Lavage and Local Antibiotics | Experimental | Drug: Topical Antibiotic, Drug: Saline Lavage Solution1 litre of sterile isotonic saline solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure. |
| Povidone-iodine Lavage Solution with no Local Antibiotics | Experimental | Drug: Povidone-Iodine Lavage Solution1 litre of 0.35% povidone-iodine lavage solution will be used immediately prior to closure. |
| Chlorhexidine Lavage Solution with no Local Antibiotics | Experimental | Drug: Chlorhexidine Lavage Solution1 litre of 0.05% chlorhexidine lavage solution will be used immediately prior to closure. |
| Normal Saline Lavage with no Local Antibiotics | Active comparator | Drug: Saline Lavage Solution1 litre of sterile isotonic saline solution will be used immediately prior to closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older.
- Undergoing primary or revision TJR.
- Informed consent obtained.
Key exclusion criteria (16 listed)
- Received antibiotics for any reason in the two weeks prior to their TJR.
- Chronic or acute infection at or near the TJR site.
- Prior history of PJI.
- Undergoing surgery for a diagnosis of a fracture.
- Open wounds on affected limb.
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 |
|---|---|---|
| Povidone-Iodine Lavage Solution0.35% povidone-iodine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.35% povidone-iodine and sterile isotonic saline solution may also be used. | Drug | Povidone-iodine Lavage Solution with no Local Antibiotics, Povidone-iodine Lavage and Local Antibiotics |
| Chlorhexidine Lavage Solution0.05% chlorhexidine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.05% chlorhexidine and sterile isotonic saline may also be used. | Drug | Chlorhexidine Lavage Solution with no Local Antibiotics, Chlorhexidine Lavage and Local Antibiotics |
| Topical Antibiotic2 grams Vancomycin powder | Drug | Chlorhexidine Lavage and Local Antibiotics, Normal Saline Lavage and Local Antibiotics, Povidone-iodine Lavage and Local Antibiotics |
| Saline Lavage Solution1 litre of sterile isotonic saline | Drug | Normal Saline Lavage and Local Antibiotics, Normal Saline Lavage with no Local Antibiotics |
Primary outcome
Feasibility of a Definitive Trial based on the following criteria domains: 1) Participant Enrollment, 2) Administration of Treatments, 3) Data Collection Methods, and 4)Compliance with the Protocol.
Time frame: 2 - 2.5 years
Each domain will be interpreted via a "traffic light" approach, in which "green" will indicate moving forward as is with the definitive trial, "yellow" will mean proceeding with some modifications, and "red" will indicate that the definitive trial is not feasible. Feasibility criteria will be monitored over the course of the pilot study and modifications will be made to the protocol during the pilot phase to increase feasibility.
1 secondary outcome
Persistent Wound Drainage (PWD) and Periprosthetic Joint Infections (PJI) requiring reoperation
Time frame: Within 90 days of the Total Joint Replacement Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Thomas Wood, MD principal investigator
McMaster University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Povidone-Iodine Lavage Solution, Chlorhexidine Lavage Solution and Topical Antibiotic in people with Periprosthetic Joint Infection and Draining Wound, run by McMaster University at 6 sites in 2 countries.
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 3 inclusion and 16 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: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a Definitive Trial based on the following criteria domains: 1) Participant Enrollment, 2) Administration of Treatments, 3) Data Collection Methods, and 4)Compliance with the Protocol. (time frame: 2 - 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.