Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

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

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.

Study Overview

• Status: Terminated
• Conditions: Gustilo-Anderson Type III Open Tibia Fracture
• Intervention / Treatment: Drug: Saline; Drug: Irrisept (Irrigation Solution)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Saline; Saline irrigation
Experimental: 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.	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.
Experimental: 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.	Drug: Saline; Saline irrigation
Experimental: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Surgical Site Infection (SSI)	Measured by the number of surgical site infections in the total population of patients.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Fracture Healing	Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon.	6 months

Collaborators and Investigators

• Sponsor: Brett D. Crist

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Tibial Fractures
• Other Study ID Numbers: 2086908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No