Irrisept Trauma Study

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Control Trial Comparing Temporary External Fixator to Antibiotic-coated IM Nail for Open Tibia Fractures

Conditions
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Gustilo-Anderson Type III Open Tibia Fracture

Intervention / Treatment
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* Drug: Irrisept (Irrigation Solution)
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, 18 or over Gustilo-Anderson type III open tibia fracture Able to obtain informed consent from patient Exclusion Criteria: Minor, under 18 Pregnancy Prisoner Allergic to chlorhexidine gluconate Allergic to vancomycin or tobramycin Patient's tibia is unable to accommodate the smallest antibiotic nail Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be enrolled and randomized into one of four groups: Standard operative debridement and spanning external fixator (reference/control group) Spanning external fixator with Irrisept irrigation (treatment group 1) Antibiotic-coated medullary nail with saline irrigation (treatment group 2) or Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard operative debridement and spanning external fixator (reference/control group)<br>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. | Drug: Saline<br>* Saline irrigation<br>|
| Experimental: Spanning external fixator with Irrisept irrigation (treatment group 1)<br>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. | Drug: Irrisept (Irrigation Solution)<br>* Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.<br>|
| Experimental: Antibiotic-coated medullary nail with saline irrigation (treatment group 2)<br>Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline. | Drug: Saline<br>* Saline irrigation<br>|
| Experimental: Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)<br>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). | Drug: Irrisept (Irrigation Solution)<br>* Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surgical site infection (SSI) | Rate of surgical site infection (SSI) and wound complications following surgery. Measured by the number of surgical site infections in the total population of patients in the cohort. Deep infection indicates return to the operating room. Superficial infection indicates local wound care and oral antibiotics. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture Healing | Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon | 6 months |