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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
Is undergoing one or more procedures to address the included fractures listed below for one or more (at least one) HELEF at high-risk for SSI: Open tibia fractures, Open femur fractures, Open or closed tibial plateau fractures, Open or closed tibial pilon fractures, Open or closed calcaneus fractures, Open or closed talus fractures, Open or closed foot fractures of any bone EXCEPT the toes, Open fibula fractures, Open rotational ankle fractures (malleoli), Open or closed leg fractures associated with compartment syndrome. Examples of included procedures: Excisional debridement of open fracture, femur and/or tibia, Intramedullary nail, tibia (open injury), Intramedullary nail, femur (open injury), Open reduction Pilon/Plafond fracture, Open reduction tibial plateau fracture, Open reduction calcaneal fracture, Open reduction Lisfranc/metatarsal associated with crush injury, Open reduction talus, External fixation, lower extremity tibia or femur associated with open fracture or compartment syndrome, Fasciotomy, lower extremity for compartment syndrome related to femur, tibia, or foot fracture, Lower extremity amputation related to HELEF
Age > 18 years of age
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery for a high-risk fracture in my leg or foot.
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I am older than 18 years.

POTENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 180 days of the initial surgical procedure for helef repair
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 180 days of the initial surgical procedure for helef repair for reporting.

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 more

POTENT 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
1,633 Previous Clinical Trials
2,558,157 Total Patients Enrolled
PDI HealthcareUNKNOWN
University of TexasOTHER
186 Previous Clinical Trials
140,479 Total Patients Enrolled

Media Library

Povidone-Iodine Topical Ointment (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT05763602 — Phase 4
Surgical Site Infection Research Study Groups: Nasal Povidone-Iodine Decolonization Intervention, Concurrent Control
Surgical Site Infection Clinical Trial 2023: Povidone-Iodine Topical Ointment Highlights & Side Effects. Trial Name: NCT05763602 — Phase 4
Povidone-Iodine Topical Ointment (Antiseptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763602 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of recruitment for this medical trial?

"This medical trial necessitates 2000 patients meeting the eligibility requirements to take part in it. Those interested can enroll at either University of Indiana's Indianapolis campus or University of Iowa in Iowa City."

Answered by AI

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
~690 spots leftby Feb 2025