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Topical Antibiotic Irrigation for Surgical Site Infection
Phase 4
Recruiting
Led By Nagi Demian, MDDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing whether gentamycin can help reduce surgical site infections in midfacial fracture surgery.
Who is the study for?
This trial is for patients scheduled for midfacial fracture surgery at Memorial Hermann hospital, Texas Medical Center. Participants must be able to sign their own consent and should not have infected surgical sites or allergies to bacitracin.Check my eligibility
What is being tested?
The study compares the effectiveness of gentamicin (an antibiotic) irrigation versus sterile normal saline in preventing infections after midfacial fracture surgery. It also looks at whether intravenous prophylactic antibiotics can be beneficial.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to gentamicin, irritation at the surgical site from topical application, and general risks associated with antibiotic use such as nausea or rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery to fix fractures in the middle of my face.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with surgical site infection (SSI)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: topical irrigation with the antibiotic bacitracinExperimental Treatment2 Interventions
Fractures will be irrigated with Bacitracin topical antibiotic (50,000 units) prior to closure. All groups with receive standard parenteral intravenous (IV) prophylactic antibiotic.
Group II: topical irrigation with sterile normal saline (NS)Active Control2 Interventions
Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,781 Total Patients Enrolled
Nagi Demian, MDDS4.25 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
5Patient Review
Dr. Demian provides top-tier care and has been treating my wife for over a year now. Originally, her jawbone was breaking down due to infection. He removed the infected part and put in a metal plate, but her skin receded back over the plate and split. There was a hole in her chin with metal plate sticking out. He scheduled her for another major surgery. During prep, when he came into the room, she jumped up and gave him a HUGE hug, even knowing what he had to do. The man believes there is no care but the BEST CARE.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am capable of understanding and signing my own consent.I have an infection at a surgery site.I am scheduled for surgery to fix fractures in the middle of my face.
Research Study Groups:
This trial has the following groups:- Group 1: topical irrigation with sterile normal saline (NS)
- Group 2: topical irrigation with the antibiotic bacitracin
Awards:
This trial has 4 awards, including:- 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.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
What clinical ailments can topical irrigation with bacitracin help alleviate?
"Bacitracin is typically used for treating skin ulcers, although it can also be applied topically to reduce inflammation and eliminate infected wounds. Additionally, the antibiotic has been known to treat empyema effectively."
Answered by AI
Are there any recorded instances of bacitracin being used topically for irrigation purposes?
"At present, two clinical trials are evaluating the efficacy of bacitracin for topical irrigation. One study is in Phase 3 and both sites are situated within Umeå Västerbotten."
Answered by AI
Is sign-up for this experiment ongoing at present?
"The clinical trial is currently open for recruitment, as indicated on the information found at clinicaltrials.gov; it was initially posted on October 9th 2018 and modified most recently in August 14th 2022."
Answered by AI
Can topical irrigation with bacitracin be used without consequence?
"The safety of topical irrigation with bacitracin was rated 3 on a scale from 1 to 3 due to its Phase 4 status, which denotes that it has been authorized by the relevant authorities."
Answered by AI
What is the total participant capacity for this experiment?
"Affirmative. According to information available on clinicaltrials.gov, this scientific investigation is currently recruiting participants and was first published on October 9th 2018 with a recent update dated August 14th 2022. 200 subjects are required from one medical setting."
Answered by AI
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