What side effects are associated with this type of intervention?

The use of antibiotic cement coated intramedullary nails for open tibia fractures can lead to side effects such as local tissue irritation, allergic reactions, and potential systemic toxicity from antibiotic absorption. There is also a risk of infection if the procedure is not sterile. Irrisept, a wound irrigant, may cause local irritation, allergic reactions, and potential cytotoxicity to surrounding tissues. Both treatments are designed to reduce infection rates but come with associated risks.

What prior FDA approvals exist?

The FDA has approved various treatments for open tibia fractures, including the use of antibiotic cement-coated intramedullary nails, which deliver antibiotics locally to prevent infection. This method is particularly useful in managing infected long bone fractures. Additionally, wound irrigation solutions like Irrisept, which contains chlorhexidine, have been used to lower infection rates in different wound settings, although robust data specifically for open tibia fractures are limited. These treatments aim to reduce deep infection rates and improve healing outcomes in patients with severe open fractures.

What other types of research exist?

Promising novel alternatives for open tibia fracture treatment in 2024 may include: 1) Advanced drug delivery systems such as bioresorbable antibiotic-eluting implants, which provide controlled and sustained release of antibiotics directly at the fracture site. 2) Novel antimicrobial agents like bacteriophage therapy, which targets specific bacterial infections without affecting beneficial bacteria. 3) Innovative wound care technologies such as negative pressure wound therapy (NPWT) combined with instillation, which enhances wound cleaning and promotes healing by delivering topical solutions directly to the wound site.

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Antibiotic

Irrisept for Open Tibia Fractures

Phase 4

Waitlist Available

Research Sponsored by Brett D. Crist

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gustilo-Anderson type III open tibia fracture

Be older than 18 years old

Must not have

Unable to provide informed consent

Minor, under 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include reactions at the site of treatment such as irritation from Irrisept or complications related to the use of antibiotic-coated nails like local allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a severe open fracture in my tibia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to understand and give consent for treatment.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Experiencing Surgical Site Infection (SSI)

Secondary study objectives

Number of Participants With Fracture Healing

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Spanning external fixator with Irrisept irrigation (treatment group 1)Experimental Treatment1 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 Treatment1 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 Treatment1 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 Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Saline

2013

Completed Phase 4

~2130

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibiotic Cement Coated Intramedullary Nails work by delivering antibiotics directly to the site of the fracture, which helps to prevent and treat infections locally, reducing the risk of deep infections that are common in open fractures. This local delivery system ensures high concentrations of antibiotics at the site of injury, which is crucial for effective infection control. Irrisept, a wound irrigant, is used to cleanse the wound and lower infection rates by removing debris and bacteria from the wound site. This helps to create a cleaner environment that promotes healing and reduces the risk of infection. These treatments are particularly important for open tibia fracture patients because they address the high risk of infection associated with these injuries, thereby improving outcomes and reducing complications.

Find a Location

Who is running the clinical trial?

Brett D. CristLead Sponsor

Brett CristLead Sponsor

1 Previous Clinical Trials

7 Total Patients Enrolled

Media Library

Antibiotic Cement Coated Intramedullary Nails (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05402995 — Phase 4

$Severe open fracture Research Study Groups: Antibiotic-coated medullary nail with saline irrigation (treatment group 2), Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3), Standard operative debridement and spanning external fixator (reference/control group), Spanning external fixator with Irrisept irrigation (treatment group 1)$

$Severe open fracture Clinical Trial 2023: Antibiotic Cement Coated Intramedullary Nails Highlights & Side Effects. Trial Name: NCT05402995 — Phase 4$