Fractures, Open
Conditions
Brief summary
The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.
Interventions
DRUGTobramycin
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18 - 70 years * Gustilo Type I,II,IIIa open fracture (s) * Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated) * Subject should be able to follow up at the scheduled times following surgery * Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study
Exclusion criteria
* Closed fracture * Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively) * Aminoglycoside allergy * Presentation greater than 48 hours after injury * Pathologic fracture * Preexisting infection in bone with an open fracture * Patients with multiple trauma involving liver, kidney, or brain * Pregnancy (self-reported) * Current status as prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Wound Infection | 6 weeks post op | Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antibiotic Subjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.
Tobramycin | 8 |
| Normal Saline Subjects will be injected locally with 40 mL 0.9% NS after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.
Placebo: normal saline | 3 |
| Total | 11 |
Baseline characteristics
| Characteristic | Antibiotic | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 3 Participants | 11 Participants |
| Region of Enrollment United States | 8 participants | 3 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 3 |
| other Total, other adverse events | 0 / 8 | 0 / 3 |
| serious Total, serious adverse events | 0 / 8 | 1 / 3 |
Outcome results
Primary
Presence of Wound Infection
Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
Time frame: 6 weeks post op
Population: We were only able to enroll 11 patients in this study. Our target n for recruitment for statistical significance was 120. Therefore, we did not perform statistical tests.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antibiotic | Presence of Wound Infection | 0 Participants |
| Normal Saline | Presence of Wound Infection | 0 Participants |