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NCT05763602RECRUITINGIRB Ready

PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)

(POTENT)

Sponsored by Loreen Herwaldt

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 2000 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this study is to see whether applying povidone iodine (PVI) to the noses of patients undergoing lower extremity (leg, ankle, or foot) orthopedic fixation procedures of high-energy lower extremity fractures (HELEF) will decrease the patients' risk of surgical site infections (SSI), particularly those caused by Staphylococcus aureus.

Who Can Participate

Inclusion Criteria

Age \> 18 years of age.
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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

2000 participants

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Gender

ALL

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Sponsor

Loreen Herwaldt

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Indianapolis

Indiana

Location available
View Indianapolis location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

St Louis

Missouri

Location available
View St Louis location page
NOT_YET_RECRUITING

Dallas

Texas

Location available
View Dallas location page
RECRUITING

Salt Lake City

Utah

Location available
View Salt Lake City location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Leg Fractures Treatment in Atlanta?

Join others in Georgia exploring innovative treatment options through clinical research

Leg Fractures Treatment Options in Atlanta, Georgia

If you're searching for Leg Fractures treatment in Atlanta, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Atlanta, Indianapolis, Iowa City and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Leg Fractures. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Georgia
Now Enrolling
Up to 2000 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Leg Fractures?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Leg Fractures

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Leg Fractures Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05763602. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.