Gustilo-Anderson Type III Open Tibia Fracture
Conditions
Brief summary
Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. At the University of Missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in Gustilo-Anderson type III fractures, prompting the study that is being proposed here. Antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. Since external fixation and staged debridement did not decrease type III open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. Additionally, Irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. To the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. The purpose of this study is to determine the effects of Irrisept and antibiotic nails on lowering deep infection rates in type III open tibia fractures.
Interventions
DRUGIrrisept (Irrigation Solution)
Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
DRUGSaline
Saline irrigation
Sponsors
Brett D. Crist
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be enrolled and randomized into one of four groups: 1. Standard operative debridement and spanning external fixator (reference/control group) 2. Spanning external fixator with Irrisept irrigation (treatment group 1) 3. Antibiotic-coated medullary nail with saline irrigation (treatment group 2) or 4. Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult, 18 or over 2. Gustilo-Anderson type III open tibia fracture 3. Able to obtain informed consent from patient
Exclusion criteria
1. Minor, under 18 2. Pregnancy 3. Prisoner 4. Allergic to chlorhexidine gluconate 5. Allergic to vancomycin or tobramycin 6. Patient's tibia is unable to accommodate the smallest antibiotic nail 7. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Surgical Site Infection (SSI) | 90 days | Measured by the number of surgical site infections in the total population of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fracture Healing | 6 months | Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.
Saline: Saline irrigation | 0 |
| Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. | 2 |
| Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Saline: Saline irrigation | 2 |
| Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Study terminated due to lack of enrollment and followup. | 0 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 6 Participants | 2 Participants | 2 Participants | 2 Participants | — |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 2 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 0 | 0 / 2 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 2 | 1 / 2 | 0 / 2 |
Outcome results
Primary
Number of Participants Experiencing Surgical Site Infection (SSI)
Measured by the number of surgical site infections in the total population of patients.
Time frame: 90 days
Population: As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Number of Participants Experiencing Surgical Site Infection (SSI) | 0 Participants |
| Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Number of Participants Experiencing Surgical Site Infection (SSI) | 0 Participants |
| Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Number of Participants Experiencing Surgical Site Infection (SSI) | 0 Participants |
| Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | Number of Participants Experiencing Surgical Site Infection (SSI) | 0 Participants |
Secondary
Number of Participants With Fracture Healing
Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon.
Time frame: 6 months
Population: As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group. Unable to measure presence or absence of fracture callus due to lack of follow-up with study termination.