Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

Brett D. Crist

Status and phase: Terminated; Phase 4

Conditions: Gustilo-Anderson Type III Open Tibia Fracture

Treatments: Drug: Saline; Drug: Irrisept (Irrigation Solution)

Study type: Interventional

Funder types: Other

Identifiers

NCT05402995

2086908

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 4 patient groups

Standard operative debridement and spanning external fixator (reference/control group)

Active Comparator group

Description:

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.

Treatment:

Drug: Saline

Spanning external fixator with Irrisept irrigation (treatment group 1)

Experimental group

Description:

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.

Treatment:

Drug: Irrisept (Irrigation Solution)

Antibiotic-coated medullary nail with saline irrigation (treatment group 2)

Experimental group

Description:

Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.

Treatment:

Drug: Saline

Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)

Experimental group

Description:

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).

Treatment:

Drug: Irrisept (Irrigation Solution)