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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is studying whether using antibiotic-coated nails and a wound irrigant called Irrisept can lower the rate of deep infection in people with Gustilo-Anderson type III open tibia fractures.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a severe open fracture in my tibia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Surgical site infection (SSI)
Secondary outcome measures
Fracture Healing
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
~1050
Find a Location
Who is running the clinical trial?
Brett CristLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am unable to understand and give consent for treatment.I have a severe open fracture in my tibia.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Antibiotic-coated medullary nail with saline irrigation (treatment group 2)
- Group 2: Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)
- Group 3: Standard operative debridement and spanning external fixator (reference/control group)
- Group 4: Spanning external fixator with Irrisept irrigation (treatment group 1)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for enrollment in this research program?
"Affirmative. According to the clinicaltrials.gov page, this trial is actively searching for participants since its launch on June 21st 2022 and latest update in November 1st 2022. They are looking for 230 volunteers at a single centre."
Answered by AI
How many participants are partaking in this experiment?
"Affirmative. According to clinicaltrials.gov, this research program launched on June 21st 2022 and is now recruiting participants across a single medical centre for an estimated total of 230 patients."
Answered by AI
What potential hazards are associated with usage of Irrisept (Irrigation Solution)?
"The safety of Irrisept (Irrigation Solution) is rated 3, due to its Phase 4 trial status. This indicates that the treatment has been approved for use by physicians and patients alike."
Answered by AI
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