Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

Phase 4

Terminated

• Conditions: Gustilo-Anderson Type III Open Tibia Fracture
• Interventions: Drug: Saline; Drug: Irrisept (Irrigation Solution)

• Registration Number: NCT05402995
• Lead Sponsor: Brett D. Crist

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Study Start: 2022-06-21
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Results First Submitted: 2023-11-30
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Results First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard operative debridement and spanning external fixator (reference/control group)	Saline	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.
Spanning external fixator with Irrisept irrigation (treatment group 1)	Irrisept (Irrigation Solution)	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.
Antibiotic-coated medullary nail with saline irrigation (treatment group 2)	Saline	Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)	Irrisept (Irrigation Solution)	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Missouri Health System; 🇺🇸 Columbia, Missouri, United States