Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05421741
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Open Tibia Fracture
  • Osteomyelitis Tibia
  • Tibial Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Antibiotic coated intramedullary Nail — DRUG
    Antibiotic coated intramedullary nail: A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.
  • Standard Intramedullary Nail — OTHER
    Standard Intramedullary Nail

Study Details

This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.

Key Dates

Start date
May 15, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
484 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intramedullary Nail
    Traditional standard of care intramedullary (IM) nail
  • Active Comparator: Antibiotic Coated Intramedullary Nail
    Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.

Primary Outcome Measure

Number of Participants who develop deep surgical site infection (SSI) [ Time Frame: Day 30 through month 12 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Florida GainesvilleGainesvilleFlorida32607
Michael Talerico, MD
Marissa Pazik
Florida Orthopaedic InstituteTemple TerraceFlorida33637
Lisa Stang
Hassan Mir, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health NavicentMaconGeorgia31201
Jarrod Dumpe, MD
Jarrod Dumpe, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40536
Paul Matuszewski, MD
Paul Matuszewski, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina Chapel HillChapel HillNorth Carolina27546
Andrew Chen, MD
Malvika Choudhari
Atrium Health Carolinas Medical CenterCharlotteNorth Carolina28203
Rachel B Seymour, PhD
Christine Churchill, MA
Joseph R Hsu, MD (PRINCIPAL_INVESTIGATOR)
Rachel B Seymour, PhD (SUB_INVESTIGATOR)
Kevin Phelps, MD (SUB_INVESTIGATOR)
Madhav Karunakar, MD (SUB_INVESTIGATOR)
Stephen Sims, MD (SUB_INVESTIGATOR)
Laurence Kempton, MD (SUB_INVESTIGATOR)
Meghan Wally, PhD (SUB_INVESTIGATOR)
Susan Odum, PhD (SUB_INVESTIGATOR)
Atrium Health CabarrusConcordNorth Carolina28025
Luke Harmer, MD
Erica Grochowski, MPH
Luke Harmer, MD (PRINCIPAL_INVESTIGATOR)
Laura Blum, MD (SUB_INVESTIGATOR)
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Martha Holden
Eben Carroll, MD (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033
Jana Davis, MD
[email protected]
Uzma Muzammil
[email protected]
Vanderbilt University Medical CenterNashvilleTennessee37232
Karen Trochez
Daniel Stinner, MD (PRINCIPAL_INVESTIGATOR)
University of Texas HoustonHoustonTexas77030
Stephen Warner, MD
Natasha Howard
San Antonio Military Medical CenterSan AntonioTexas78234
Raymond Kessler, MD
Raymond Kessler, MD (PRINCIPAL_INVESTIGATOR)
Carilion ClinicRoanokeVirginia24016
Cody Evans, MD
[email protected]
540-510-6200
Cody Evans, MD (PRINCIPAL_INVESTIGATOR)
Valley Health SystemWinchesterVirginia22601
Kenneth Nelson, MD
[email protected]
Ashley Zelaski
[email protected]

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University of Florida Gainesville· Gainesville, FLFlorida Orthopaedic Institute· Temple Terrace, FLAtrium Health Navicent· Macon, GAUniversity of Kentucky· Lexington, KYUniversity of North Carolina Chapel Hill· Chapel Hill, NCAtrium Health Carolinas Medical Center· Charlotte, NC

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