Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

NCT ID: NCT05402995

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2023-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

Saline irrigation

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.

Group Type: EXPERIMENTAL

Irrisept (Irrigation Solution)

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Saline

Intervention Type: DRUG

Saline irrigation

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).

Group Type: EXPERIMENTAL

Irrisept (Irrigation Solution)

Intervention Type: DRUG

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

Interventions

Irrisept (Irrigation Solution)

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

Intervention Type: DRUG

Saline

Saline irrigation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brett D. Crist

OTHER

Sponsor Role: lead

Responsible Party

Brett D. Crist

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

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Missouri Health System

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2086908

Identifier Type: -

Identifier Source: org_study_id