Clinical trial NCT05402995: Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention
Official title: Prospective Randomized Control Trial Comparing Irrisept to Saline Irrigation for the Prevention of Infection After Open Tibia Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gustilo-Anderson Type III Open Tibia Fracture
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Experiencing Surgical Site Infection (SSI)
timeFrame: 90 days
Secondary outcomes:
measure: Number of Participants With Fracture Healing
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
Study officials:
References: