Irrisept for Open Tibia Fractures

Overseen By Stacee Baker, MEd BSN RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brett D. Crist

Disqualifiers: Pregnancy, Prisoner, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate surgical intervention

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests new treatments to reduce infections in patients with severe open leg fractures. The treatments aim to deliver medicine directly to the fracture site and thoroughly clean the wound. These new methods have been shown to help in healing and reducing the risk of infection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Irrisept for Open Tibia Fractures?

Research shows that using antibiotic cement-coated intramedullary nails is effective for treating open fractures, with high success rates in controlling infections and achieving bone healing. In studies, these nails helped 90% of patients with open tibia fractures heal successfully, making them a promising option for managing such injuries. ^{1 2 3 4 5}

Is Irrisept safe for treating open tibia fractures?

Research on antibiotic-coated nails, which are similar to Irrisept, shows they are generally safe for treating open tibia fractures. Studies report no systemic toxicity or local hypersensitivity, and they effectively control infections with minimal side effects. ^{1 4 6 7 8}

How does the treatment with antibiotic cement coated intramedullary nails differ from other treatments for open tibia fractures?

This treatment is unique because it combines the stabilization of fractures with the delivery of high concentrations of antibiotics directly at the infection site, reducing the need for prolonged antibiotic therapy. It allows for early weight-bearing and has shown high success rates in controlling infections and achieving bone healing. ^{1 3 5 9 10}

Eligibility Criteria

Adults over 18 with a type III open tibia fracture who can give informed consent. Excluded are minors, those unable to consent, allergic to vancomycin or tobramycin, prisoners, if the smallest antibiotic nail doesn't fit their tibia, pregnant women, and anyone allergic to chlorhexidine gluconate.

Inclusion Criteria

Able to obtain informed consent from patient

I am 18 years old or older.

I have a severe open fracture in my tibia.

Exclusion Criteria

Pregnancy

Allergic to vancomycin or tobramycin

Allergic to chlorhexidine gluconate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical procedures including irrigation and debridement with either Irrisept or saline, and fixation with antibiotic-coated nails or external fixators

Immediate surgical intervention

Multiple visits for surgical procedures

Follow-up

Participants are monitored for surgical site infections and fracture healing

6 months

Regular follow-up visits for monitoring infection and healing

Treatment Details

Interventions

• Antibiotic Cement Coated Intramedullary Nails
• Irrigation with Irrisept

Trial Overview The study is testing whether Irrisept (a wound cleaning solution) and antibiotic-coated nails can reduce infection rates in severe open tibia fractures compared to standard treatments. Patients will receive either Irrisept or saline during initial surgery.

Participant Groups

Group I: Spanning external fixator with Irrisept irrigation (treatment group 1) Experimental Treatment 1 Intervention

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 II: Antibiotic-coated medullary nail with saline irrigation (treatment group 2) Experimental Treatment 1 Intervention

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

Group III: Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3) Experimental Treatment 1 Intervention

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 IV: Standard operative debridement and spanning external fixator (reference/control group) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Brett D. Crist

Lead Sponsor

Trials

1

Recruited

6+

Brett Crist

Lead Sponsor

Trials

2

Recruited

10+

Findings from Research

The interlocking antibiotic cement-coated nail technique effectively eradicated infection and achieved fracture healing in 85.4% of the 41 patients treated for infected nonunion after intramedullary nailing.

Even among the 6 patients who initially had persistent infections, 5 eventually healed with further treatment, demonstrating the overall efficacy of this approach in managing complex cases of nonunion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic Cement-Coated Interlocked Intramedullary Nails for the Treatment of Infected Nonunion After Intramedullary Nailing. Zalikha, AK., Sayeed, Z., Stine, SA., et al.[2023]

Antimicrobial-coated intramedullary nails show a high infection eradication rate of 90% and a bone consolidation rate of 85.5% in treating infected non-unions of the femur and tibia, based on a review of 22 publications involving 506 cases.

Despite the promising results, most studies were retrospective case series with low scientific quality, highlighting the need for randomized controlled trials to better assess the efficacy and safety of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual and commercially available antimicrobial coatings for intramedullary nails for the treatment of infected long bone non-unions - a systematic review. Walter, N., Rupp, M., Krückel, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Results of Antibiotic-Impregnated Cement/Polymer-Coated Intramedullary Nails in the Management of Infected Nonunion and Open Fractures of Long Bones. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Antibiotic Cement-Coated Interlocked Intramedullary Nails for the Treatment of Infected Nonunion After Intramedullary Nailing. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Tibia Antibiotic Intramedullary Nail. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Antibiotic-Coated Nail in Open Tibial Fracture: A Retrospective Case Series. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Implant-related infection in the tibia: surgical revision strategy with vancomycin cement. [2018]

6. Italy pubmed.ncbi.nlm.nih.gov

Intramedullary antibiotic coated nail in tibial fracture: a systematic review. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Individual and commercially available antimicrobial coatings for intramedullary nails for the treatment of infected long bone non-unions - a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Uncoated vs. Antibiotic-Coated Tibia Nail in Open Diaphyseal Tibial Fracture (42 according to AO Classification): A Single Center Experience. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Treatment of infection following intramedullary nailing of tibial shaft fractures-results of the ORS/ISFR expert group survey. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Anti-infective efficacy of antiseptic-coated intramedullary nails. [2019]