Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

NCT05402995 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2086908
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Gustilo-Anderson Type III Open Tibia Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Fracture Healing

  6 months

Study Arms (4)

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

ACTIVE COMPARATOR

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

Spanning external fixator with Irrisept irrigation (treatment group 1)

EXPERIMENTAL

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)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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)

Interventions

Irrisept (Irrigation Solution) DRUG

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

Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3); Spanning external fixator with Irrisept irrigation (treatment group 1)

Saline DRUG

Saline irrigation

Antibiotic-coated medullary nail with saline irrigation (treatment group 2); Standard operative debridement and spanning external fixator (reference/control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brett D. Crist: lead

Study Sites (1)

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Vicki L Jones
• Organization: UMissouri

jonesvicki@health.missouri.edu

573-882-7583

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director Orthopaedic Trauma Service, Director Orthopaedic Trauma Fellowship, Surgery of the Hip and Trauma, Department of Orthopaedic Surgery

Model Details: Participants will be enrolled and randomized into one of four groups: 1. Standard operative debridement and spanning external fixator (reference/control group) 2. Spanning external fixator with Irrisept irrigation (treatment group 1) 3. Antibiotic-coated medullary nail with saline irrigation (treatment group 2) or 4. Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: June 2, 2022
• Study Start: June 21, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)