Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years or older
Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Disqualifiers
Less than 18 years of age
Allergy to vancomycin or gentamicin
Unable to speak English or Spanish
Pregnant and lactating women
Trial design
Design model
Parallel
Treatments tested in this trial
Antibiotic coated intramedullary Nail
DrugAntibiotic 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 interventionStandard Intramedullary Nail
Treatment groups
242 Participants
are divided into 2 treatment groupsGroup A: Intramedullary NailActive comparator 1 intervention
Group B: Antibiotic Coated Intramedullary NailActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants who develop deep surgical site infection (SSI)
Number of participants in each group who develop SSI as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Time frame
Day 30 through month 12Secondary outcomes
1
Radiographic Union Scale in Tibial fractures (RUST) score
The RUST score ranges from a minimum score of 4 (definitely not healed) to a maximum score of 12 (completely healed). The final x-ray obtained within a 12-month period following injury will be uploaded to REDCap for review by a blinded panel of investigators from participating sites.
Time frame
week 6, month 3, month 6, and month 122
Percentage of Union
Union is the gradual process of bone regeneration after a fracture. Percentage of Union, as determined by the treating surgeon, will be assessed via radiographs. Recorded by surgeon as yes/no answers.
Time frame
week 6, month 3, month 6 and month123
Time to Union
Captured in days
Time frame
week 6, month 3, month 6 and month124
Average Time to Return to Work/Duty
number of days
Time frame
week 6, month 3, month 6 and month12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov