Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

Stopped early · Phase 4

Conditions studied: Gustilo-Anderson Type III Open Tibia Fracture

In brief

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.

Key facts

Study ID

NCT05402995

Run by

Brett D. Crist

People needed

6

Starts

2022-06-21

Expected to finish

2023-08-31

Last updated by the study team

2024-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult, 18 or over
• Gustilo-Anderson type III open tibia fracture
• Able to obtain informed consent from patient

You may not qualify if…

• 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

Where it is running

• University of Missouri Health System — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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