Prosthetic-joint InfectionNCT05434260
Surgiphor vs Saline Joints
A study testing Surgiphor Irrigation Solution and Sterile saline in people with Prosthetic-joint Infection, run by Center for Innovation and Research Organization at 4 sites in United States.
Trial summary
This study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a PVP-I irrigation solution (Surgiphor) in reducing the risk of acute PJI in the 90 days following total hip and knee revision arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic-joint Infection
- What is being tested?
- Surgiphor Irrigation Solution and Sterile saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 868 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Sep 2022to Jan 2025
- 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
- Patient ≥18 years old
- Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
- Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. Subjects not willing to sign consent form to be randomized must be willing to sign alternate consent form to allow prospective data collection in the non-randomized arm of the study
Who cannot join
- Subjects with known allergies to iodine or any other ingredients in Surgiphor
- Subjects unwilling to sign informed consent
- Subjects, for health reasons or other, in the opinion of the Investigator, with a life expectancy less than one year, which is the follow-up period of the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lifebridge Health
Baltimore, Maryland, 21215
University of Missouri
Columbia, Missouri, 65212
Rothman Institute Orthopaedics
Philadelphia, Pennsylvania, 19107
University of Arizona
Phoenix, Arizona, 85724
About this study
Official title: The Use of Povidone-iodine Sterile Solution to Reduce Periprosthetic Joint Infections: a Superiority Multicentre Randomized Trial
This study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a PVP-I irrigation solution (Surgiphor) in reducing the risk of acute PJI in the 90 days following total hip and knee revision arthroplasty.
- Conditions
- Prosthetic-joint Infection
- Being tested
- Surgiphor Irrigation Solution, Sterile saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgiphor Irrigation SolutionDevice
use of Surgiphor wound irrigation solution during surgery
Sterile salineDevice
Use of sterile saline as a irrigation solution during surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgiphor: sterile povidone iodine irrigation solution | Active comparator | Surgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS Receives: Device: Surgiphor Irrigation Solution |
| Sterile saline | Placebo comparator | Not described Receives: Device: Sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of acute prosthetic joint infection
Diagnosis of acute prothetic joint infection following aseptic revision surgery
Measured: Within 90 days of revision surgery
Secondary outcomes (1)
Wound complications
Diagnosis of wound complication, surgical site infections or other infections within 1 year of surgery
Measured: within 1 year of revision surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start19 Sep 2022
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovation and Research Organization
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434260
- Sponsor's protocol ID
- Surgiphor01
- Status last verified
- Sep 2023
- First submitted
- 22 Jun 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Povidone-iodine Sterile Solution to Reduce Periprosthetic Joint Infections: a Superiority Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT05434260
- Acronym / sponsor ID
- Surgiphor01
- Conditions
- Prosthetic-joint Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 868 participants (estimated)
- Lead sponsor
- Center for Innovation and Research OrganizationResearch network
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 27 Jun 2022 (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.
This study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a PVP-I irrigation solution (Surgiphor) in reducing the risk of acute PJI in the 90 days following total hip and knee revision arthroplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgiphor: sterile povidone iodine irrigation solution | Active comparator | Device: Surgiphor Irrigation SolutionSurgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS |
| Sterile saline | Placebo comparator | Device: Sterile saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ≥18 years old
- Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
- Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. Subjects not willing to sign consent form to be randomized must be willing to sign alternate consent form to allow prospective data collection in the non-randomized arm of the study
Key exclusion criteria (3 listed)
- Subjects with known allergies to iodine or any other ingredients in Surgiphor
- Subjects unwilling to sign informed consent
- Subjects, for health reasons or other, in the opinion of the Investigator, with a life expectancy less than one year, which is the follow-up period of the study
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 |
|---|---|---|
| Surgiphor Irrigation Solutionuse of Surgiphor wound irrigation solution during surgery | Device | Surgiphor: sterile povidone iodine irrigation solution |
| Sterile salineUse of sterile saline as a irrigation solution during surgery | Device | Sterile saline |
Primary outcome
Diagnosis of acute prosthetic joint infection
Time frame: Within 90 days of revision surgery
Diagnosis of acute prothetic joint infection following aseptic revision surgery
1 secondary outcome
Wound complications
Time frame: within 1 year of revision surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgiphor Irrigation Solution and Sterile saline in people with Prosthetic-joint Infection, run by Center for Innovation and Research Organization at 4 sites in United States.
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 4 inclusion and 3 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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?
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?
Diagnosis of acute prosthetic joint infection (time frame: Within 90 days of revision surgery). 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 11 Sep 2023.