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Clinical Trials/NCT05402995
NCT05402995
Terminated
Phase 4

Prospective Randomized Control Trial Comparing Irrisept to Saline Irrigation for the Prevention of Infection After Open Tibia Fractures

Brett D. Crist1 site in 1 country6 target enrollmentJune 21, 2022

Overview

Phase
Phase 4
Intervention
Saline
Conditions
Gustilo-Anderson Type III Open Tibia Fracture
Sponsor
Brett D. Crist
Enrollment
6
Locations
1
Primary Endpoint
Number of Participants Experiencing Surgical Site Infection (SSI)
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 21, 2022
End Date
August 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Brett D. Crist
Responsible Party
Sponsor Investigator
Principal Investigator

Brett D. Crist

Professor, Director Orthopaedic Trauma Service, Director Orthopaedic Trauma Fellowship, Surgery of the Hip and Trauma, Department of Orthopaedic Surgery

University of Missouri-Columbia

Eligibility Criteria

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
  • 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

Arms & Interventions

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

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.

Intervention: Saline

Spanning external fixator with Irrisept irrigation (treatment group 1)

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.

Intervention: Irrisept (Irrigation Solution)

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

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

Intervention: Saline

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

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).

Intervention: Irrisept (Irrigation Solution)

Outcomes

Primary Outcomes

Number of Participants Experiencing Surgical Site Infection (SSI)

Time Frame: 90 days

Measured by the number of surgical site infections in the total population of patients.

Secondary Outcomes

  • Number of Participants With Fracture Healing(6 months)

Study Sites (1)

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