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Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

NCT05402995 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-04-24

Study results available
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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.

Conditions

  • Gustilo-Anderson Type III Open Tibia Fracture

Interventions

DRUG

Irrisept (Irrigation Solution)

Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

DRUG

Saline

Saline irrigation

Sponsors & Collaborators

  • Brett D. Crist

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402995 on ClinicalTrials.gov