Lexington, KYNCT04678154Now EnrollingIRB Ready

Severe Open Fractures Clinical Trial in Lexington, KY

Access cutting-edge severe open fractures treatment through this phase 3 clinical trial at a research site in Lexington. Study-provided care at no cost to qualified participants.

Sponsored by Major Extremity Trauma Research Consortium

Quick Self-Assessment

See if you qualify for this Lexington location

Preparing your pre-screening questions…

Expert Care in Lexington

Access severe open fractures specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related severe open fractures treatment provided free

Apply for This Lexington Location

Check if you qualify for this severe open fractures clinical trial in Lexington, KY

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Local to Lexington

    Convenient for KY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Lexington site if eligible
  4. 4Begin participation

About This Severe Open Fractures Study in Lexington

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

Sponsor: Major Extremity Trauma Research Consortium

Who Can Participate

Inclusion Criteria

Injury meeting at least one of the following criteria: a. Gustilo type III fractures of the tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon); ankle (OTA 44); calcaneus (OTA 82) and/or talus (OTA 81) with injury characteristics meeting at least one of the following criteria: i. All IIIB fractures ii. IIIA fractures that require a planned second debridement prior to definitive closure / coverage iii. IIIA fractures with extensive contamination or muscle damage precluding definitive internal fixation at the time of initial surgery iv. IIIA fractures with extensive degloving or wound greater than 10 cm after debridement (if indicated, primary wound closure is allowed. Primary wound closure refers to the definitive closure of the wound at the initial surgical event, without plans for re-entry for additional debridement and/or fracture fixation) v. IIIA fractures severe fracture comminution resulting from high energy trauma (if indicated, primary wound closure/coverage is allowed) vi. IIIA fractures with AO/OTA OFC contamination level of severe with material imbedded into bone or soft tissue or with a severe high risk environmental contamination from farm, fecal, dirty water inoculation or other equivalent (if indicated, primary wound closure/coverage is allowed) vii. IIIA Fractures where the skin could be closed after extensive muscle or bone removal (if indicated, primary wound closure/coverage is allowed) viii. IIIA fractures with bone loss resulting in a circumferential gap of 1 cm after debridement (if indicated, primary wound closure/coverage is allowed) ix. Fractures where fasciotomies were performed for impending or diagnosed compartment syndromes (regardless of the initial open or closed classification of the fracture x. Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
Ages 18 - 64 years inclusive
Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
Patients may have a traumatic brain injury.
Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur, or foot injuries.
Patients may be treated initially at an outside institution prior to transferring to the study institution, as long as the definitive wound closure/coverage was not performed prior to entrance into the study.
Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
Patients may have co-existing non-tibial or hindfoot infections, with or without antibiotic treatment.
Patients may be definitively stabilized using any method (nail, plate, ex fix, or cast).
Patients may have fasciotomy.

Exclusion Criteria

Patient speaks neither English or Spanish
Patient in current therapy for a wound, implant or fracture site infection related to the study site.
Patient is pregnant, potentially pregnant, or lactating.
Patient likely to have difficulty maintaining follow-up, including:
Diagnosis of a severe psychiatric condition
Intellectually challenged without adequate family support
Resides outside of the hospital's catchment area, unless willing to follow-up by phone or telemedicine
Planning to follow-up at another medical center, unless willing to follow-up by phone or telemedicine
Being a prisoner
Not having a means of contact (address, cell phone, home phone, e-mail)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lexington?

Yes, this clinical trial (NCT04678154) has an active research site in Lexington, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Severe Open Fractures Treatment Options in Lexington, KY

If you're searching for severe open fractures treatment options in Lexington, KY, this clinical trial (NCT04678154) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lexington research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced severe open fractures specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all severe open fractures clinical trials near you to find additional studies recruiting in your area.

More Pulmonary Embolism Trials in Lexington, KY

See all pulmonary embolism clinical trials recruiting in Lexington — not just this study.

Browse Pulmonary Embolism Trials in Lexington →

Browse More Trials by Condition

Pulmonary Embolism TrialsRheumatoid Arthritis TrialsAll Conditions →

Ready to Join in Lexington?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Lexington, KY