Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
868 participants
INTERVENTIONAL
2022-09-19
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Xperience™ vs Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty
NCT05577936
Evaluating XPERIENCE™ Advanced Surgical Irrigation
NCT05543941
Infection Prophylaxis in Total Joint Replacement
NCT06126614
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
NCT05640336
Povidone Iodine Irrıgation at Hip-Knee Arthroplasty
NCT05599841
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surgiphor: sterile povidone iodine irrigation solution
Surgiphor Wound Irrigation Solution, bottle consisting of sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS
Surgiphor Irrigation Solution
use of Surgiphor wound irrigation solution during surgery
Sterile saline
Sterile saline
Use of sterile saline as a irrigation solution during surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgiphor Irrigation Solution
use of Surgiphor wound irrigation solution during surgery
Sterile saline
Use of sterile saline as a irrigation solution during surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
4. 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
Exclusion Criteria
2. Subjects unwilling to sign informed consent
3. 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for Innovation and Research Organization
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona
Phoenix, Arizona, United States
Lifebridge Health
Baltimore, Maryland, United States
University of Missouri
Columbia, Missouri, United States
Rothman Institute Orthopaedics
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Surgiphor01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.