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New treatment option for Post Operative Surgical Site Infection
Official title Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2
ClinicalTrials.gov ID: NCT04678154
What this study is testing
What is Vancomycin and Tobramycin?
Vancomycin and Tobramycin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post operative surgical site infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the "zone-of-injury". This study will be conducted in established METRC level 1 trauma centers.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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)...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Jackson, Mississippi, United States
- Lebanon, New Hampshire, United States
- Jamaica, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
+ 8 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; West Palm Beach, Florida, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.