Clinical trial NCT05421741: Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Official title: Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteomyelitis Tibia
Tibial Fractures
Open Tibia Fracture
Keywords: Antibiotic-coated nail
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. Novel techniques for reducing infection are needed. The proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection.

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.

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.

The target population for the proposed study is patients with severe open tibia fractures (Type II or Type III) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization.

One group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1CN), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (SN).

Participant will be followed for 12 months (data capture including patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

Exclusion Criteria:

* Less than 18 years of age
* Allergy to vancomycin or gentamicin
* Unable to speak English or Spanish
* Pregnant and lactating women
* Prisoner
* Unable to follow up for 12 months

Primary outcomes:
measure: Number of Participants who develop deep surgical site infection (SSI)
timeFrame: Day 30 through month 12
Secondary outcomes:
measure: Radiographic Union Scale in Tibial fractures (RUST) score
timeFrame: week 6, month 3, month 6, and month 12
measure: Percentage of Union
timeFrame: week 6, month 3, month 6 and month12
measure: Time to Union
timeFrame: week 6, month 3, month 6 and month12
measure: Average Time to Return to Work/Duty
timeFrame: week 6, month 3, month 6 and month12
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: week 6, month 3, month 6 and month12
measure: Number of Subjects Who Have Returned to Work
timeFrame: week 6, month 3, month 6 and month12
measure: Number of Participants who Return to Operating Room (OR)
timeFrame: Month 12
measure: PROMIS-29 Subscale--Physical Function
timeFrame: week 6, month 3, month 6 and month12
measure: PROMIS-29 Subscale--Physical Function: Anxiety
timeFrame: week 6, month 3, month 6 and month12
measure: PROMIS-29 Subscale--Depression
timeFrame: week 6, month 3, month 6 and month12
measure: PROMIS-29 Subscale--Fatigue
timeFrame: week 6, month 3, month 6 and month12
measure: PROMIS-29 Subscale--Sleep Disturbance
timeFrame: week 6, month 3, month 6 and month12
measure: PROMIS-29 Subscale--Pain Interference
timeFrame: week 6, month 3, month 6 and month12
measure: PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities
timeFrame: week 6, month 3, month 6 and month12
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Gainesville
state: Florida
city: Temple Terrace
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Macon
country: United States
facility: Atrium Health Navicent
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University - University Medical Center New Orleans
state: Louisiana
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Concord
country: United States
facility: Atrium Health Cabarrus
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Winchester
country: United States
facility: Valley Health System
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph Hsu, MD
role: PRINCIPAL_INVESTIGATOR
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