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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an antibiotic cement-coated nail and a special wound wash called Irrisept can reduce deep infection rates in severe open tibia fractures. Typically, initial cleaning and temporary fixation treat these fractures, but the study seeks to assess whether adding antibiotic nails and Irrisept can improve outcomes. Participants are divided into four groups: one receiving standard care, one with Irrisept and standard fixation, one with antibiotic nails and regular saline wash, and another with antibiotic nails and Irrisept. Individuals with severe open tibia fractures who can consent and are not allergic to certain antibiotics may be suitable candidates. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

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 is the safety track record for these treatments?

Research shows that antibiotic cement-coated nails inside the bone are generally safe and effective for treating open shinbone fractures. These nails stabilize the bone and deliver high doses of antibiotics directly to the fracture, reducing infection risk and promoting healing. Success rates for these nails range from 60% to 100%, indicating they are well-tolerated.

For Irrisept, a solution used to clean wounds, the evidence is not as strong. While it is used to lower infection rates in various wounds, strong proof is lacking that it reduces infections specifically in open shinbone fractures. However, it has been used safely in other surgeries, with few post-surgical infections reported.

Both treatments appear safe based on current studies. For concerns or questions, discussing them with the trial team can provide more personalized information. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for open tibia fractures because they introduce innovative approaches to infection prevention and wound healing. Unlike the standard of care, which typically involves normal saline irrigation and external fixation, these treatments explore the use of antibiotic-coated medullary nails and an experimental irrigation solution called Irrisept. The antibiotic-coated nails deliver targeted antibiotics directly at the site of the fracture, potentially reducing infection risk more effectively than conventional methods. Additionally, Irrisept offers an advanced irrigation solution that may enhance the cleaning and debridement process compared to regular saline. These advancements could lead to quicker recovery times and better outcomes for patients with open tibia fractures.

What evidence suggests that this trial's treatments could be effective for open tibia fractures?

Research has shown that antibiotic-coated nails, one of the treatments in this trial, can effectively treat open shinbone fractures. Studies report success rates between 60% and 100% in preventing infections and aiding recovery. These nails release antibiotics directly at the fracture site, helping to stop infections. Another treatment option in this trial is irrigation with Irrisept. Although specific data on its use for open shinbone fractures is limited, it is commonly used to clean wounds and reduce infection risk. Overall, this trial aims to evaluate the effectiveness of combining these treatments to lower the risk of serious infections in severe open shinbone fractures. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 have a severe open fracture in my tibia.

Exclusion Criteria

Pregnancy

Allergic to vancomycin or tobramycin

Allergic to chlorhexidine gluconate

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138322005368

Antibiotic cement-coated intramedullary nail is cost ... Antibiotic coated intramedullary nails provide both fracture stability and high concentrations of local antibiotics directly to the open fracture site.

2. nature.com nature.com/articles/s41598-025-00934-2

Effectiveness of antibiotic-impregnated bone cement in ... All 40 patients showed no signs of infection recurrence, achieving a 100% success rate in managing postoperative infections. Radiological ...

3. injuryjournal.com injuryjournal.com/article/S0020-1383(23)00525-9/abstract

Effectiveness of antibiotic-coated intramedullary nails for ... Our findings suggest a favorable trend towards antibiotic-coated nail, with decreased risk of global infection, deep infection and non-union.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38143139/

Effectiveness of antibiotic-coated intramedullary nails for ... Our findings suggest a favorable trend towards antibiotic-coated nail, with decreased risk of global infection, deep infection and non-union.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37706117/

Results of Antibiotic-Impregnated Cement/Polymer-Coated ... Extensive research has shown promising results, with success rates ranging from 60% to 100%. Benefits of these implants include stable fracture ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8704641/

Antibiotic-Coated Nail in Open Tibial Fracture Use of antibiotic-coated nails appears to be a valid and safe option for treatment of open tibial fractures and prevention of implant-related infections.