Clinical trial NCT05766670: Intramedullary Calcium Sulfate Antibiotic Depot
Official title: Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Open tíbia Fracture
Osteomyelitis Tibia
Tibial Fractures
Keywords: antibiotic depot
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

Detailed description: This research is a randomized clinical trial aimed to reduce the frequency of fracture related infections following open tibia fracture. The proposed test methods for infection reduction is use of an antibiotic depot placed inside the bone at the time of final fracture treatment. This is in addition to standard of care wound care, fracture fixation with intramedullary nailing, and peri-operative systemic antibiotics.

This prospective randomized clinical trial will compare outcomes between patients treated with an antibiotic depot placed inside the bone at the time of final fracture fixation and those treated with traditional standard of care intramedullary nailing.

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

One group will be treated prophylactically suing a calcium sulfate antibiotic depot at the time of definitive fixation, while the second group will be treated with a standard of care intramedullary nail without the antibiotic depot.

Participants will be followed for 12 months (data capture includes 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 and older
* 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 tobramycin
* Hypercalcemia
* Unable to speak English or Spanish
* No email, phone, or other point of contact
* Pregnant and lactating women
* Prisoner

Primary outcomes:
measure: Number of participants who develop deep surgical site infection (SSI)
timeFrame: Month 12
Secondary outcomes:
measure: Number of Participants who Return to the Operating Room (OR)
timeFrame: Month 12
measure: Percentage of Union
timeFrame: week 6, month 3, month 6 and month 12
measure: Time to Union
timeFrame: week 6, month 3, month 6 and month 12
measure: Radiographic Union Scale in Tibial fractures (RUST) score
timeFrame: week 6, month 3, month 6, and month 12
measure: Presence of drainage from incision and wounds
timeFrame: week 6, month 3, month 6 and month 12
measure: Average Time to Return to Work/Duty
timeFrame: week 6, month 3, month 6 and month 12
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 3 month, 6 month, 12 month
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
measure: Veterans RAND 12 Item Health Survey (VR-12) Domain --General Health
timeFrame: week 6, month 3, month 6 and month12
measure: Veterans RAND 12 Item Health Survey (VR-12) Domain--Physical Functioning
timeFrame: week 6, month 3, month 6 and month12
measure: Veterans RAND 12 Item Health Survey (VR-12) Domain--Role Limitations
timeFrame: week 6, month 3, month 6 and month12
measure: Veterans RAND 12 Item Health Survey (VR-12) Domain--Pain
timeFrame: week 6, month 3, month 6 and month12
measure: Veterans RAND 12 Item Health Survey (VR-12) Domain--Fatigue
timeFrame: week 6, month 3, month 6 and month12
measure: Veterans Rand 12 Item Health Survey (VR-12) Domain --Social Functioning
timeFrame: week 6, month 3, month 6 and month12
measure: Veterans Rand 12 Item Health Survey (VR-12) Domain--Mental Health
timeFrame: week 6, month 3, month 6 and month12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Macon
country: United States
facility: Atrium Health Navicent The Medical Center
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
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 Medical Center
state: North Carolina
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Winchester
country: United States
facility: Valley Health
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rachel B Seymour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University Health Science Center
name: Jessica Rivera, MD
role: PRINCIPAL_INVESTIGATOR
References: