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Antiseptic
Povidone-Iodine for Surgical Site Infection (POTENT Trial)
Phase 4
Recruiting
Led By Loreen Herwaldt, MD
Research Sponsored by Loreen Herwaldt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 180 days of the initial surgical procedure for helef repair
Awards & highlights
POTENT Trial Summary
This trial will study if using a germ-killing solution in the nose can reduce risk of infection for leg surgery.
Who is the study for?
Adults over 18 facing surgery for severe leg, ankle, or foot fractures may join this trial. It's not for those allergic to iodine, pregnant women, patients with active infections at the fracture site, prisoners, individuals unable to follow up post-surgery (like homeless or intellectually challenged without support), or those who can't consent due to mental impairment.Check my eligibility
What is being tested?
The study is testing if povidone-iodine ointment in the nose reduces surgical site infections after orthopedic surgeries for serious lower extremity fractures. The focus is on preventing infections caused by Staphylococcus aureus bacteria.See study design
What are the potential side effects?
Povidone-iodine might cause local skin irritation or an allergic reaction in some people. However, since it's applied topically and not taken internally, systemic side effects are less common.
POTENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 180 days of the initial surgical procedure for helef repair
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 180 days of the initial surgical procedure for helef repair
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)
Secondary outcome measures
Clavien-Dindo assessment of postoperative complications scores
Incidence of all Complex SSI
Incidence of all Staphylococcus aureus SSI
+2 morePOTENT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nasal Povidone-Iodine Decolonization InterventionExperimental Treatment1 Intervention
Intranasal povidone-iodine (PDI Profend) will be applied to the patients' noses 60 minutes before surgery to repair HELEF and approximately 12 hours after the first application. If the patient will have additional HELEF repair in the 6 month followup period, intranasal PVI will be applied in a similar manner for each procedure.
Group II: Concurrent ControlActive Control1 Intervention
Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period.
Find a Location
Who is running the clinical trial?
Emory UniversityOTHER
1,642 Previous Clinical Trials
2,562,006 Total Patients Enrolled
PDI HealthcareUNKNOWN
University of TexasOTHER
187 Previous Clinical Trials
140,523 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery for a high-risk fracture in my leg or foot.I have a specific type of ankle fracture.I do not speak English or Spanish.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Nasal Povidone-Iodine Decolonization Intervention
- Group 2: Concurrent Control
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left in this medical experiment?
"Affirmative, clinicaltrials.gov contains data that denotes the current recruitment status of this study which launched on September 15th 2022 and was recently amended on March 6th 2023. In total, 2000 patients must be recruited from six different sites."
Answered by AI
Are any institutions in North America conducting this research experiment?
"At present, 6 clinical trial sites are seeking recruits for the medical study. Indianapolis, Iowa City and Saint Louis are among these locations as well as other cities across the nation. It is recommended to choose a nearby site if possible in order to minimize travel time should you sign up."
Answered by AI
Does the Nasal Povidone-Iodine Decolonization Intervention pose any long-term risks to patients?
"Thanks to its approval status, Nasal Povidone-Iodine Decolonization Intervention has been scored a 3 on our team's risk assessment scale."
Answered by AI
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