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Benzoyl Peroxide + Electrocautery for Prosthetic Joint Infection
Phase 4
Waitlist Available
Led By Hyunmin M Kim, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 14 days of shoulder replacement surgery
Awards & highlights
Study Summary
This trial will test if using topical benzoyl peroxide and electrocautery together can reduce C. acnes infection in shoulder replacement surgery.
Who is the study for?
This trial is for adult men over 18 who need a primary shoulder replacement due to osteoarthritis or similar conditions. It's not for those with previous shoulder infections, recent antibiotic use, active acne at the surgery site, skin condition history near the shoulder, benzoyl peroxide allergies, planned revision surgeries, minors, women, prisoners or if they can't consent in English.Check my eligibility
What is being tested?
The study tests if applying benzoyl peroxide on the skin combined with using electrocautery to make incisions reduces C. acnes bacteria during shoulder replacement surgery. Participants will be randomly chosen to either apply the topical treatment before surgery or not.See study design
What are the potential side effects?
Potential side effects may include skin irritation from benzoyl peroxide such as redness and peeling where it's applied. Electrocautery risks include burns or thermal injury at the incision site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 14 days of shoulder replacement surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 14 days of shoulder replacement surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Late dermis C. acnes culture rates
Secondary outcome measures
Mid-procedure synovium C. acnes culture rates
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Electrocautery-incision and BPO groupExperimental Treatment2 Interventions
Patients assigned in this group will undergo an application of topical benzoyl peroxide to the shoulder skin prior to shoulder replacement surgery in addition to their skin incision being made using electrocautery.
Group II: Electrocautery-incision alone groupActive Control1 Intervention
The skin inicsion will be made using electrocautery during shoulder replacement in patients assigned this group with no other preoperative treatment.
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,924 Total Patients Enrolled
Hyunmin M Kim, MDPrincipal InvestigatorUniversity of Missouri-Columbia
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active acne where my surgery will be.I am under 18 years old.I have had surgery on the same shoulder before.I have not taken antibiotics within a month before my planned surgery.I have had psoriasis or eczema near my shoulder.I am scheduled for surgery on my shoulder due to a recent fracture or poorly healed past fracture.I am a man over 18 needing shoulder replacement due to arthritis or severe rotator cuff issues.I have had an infection in the shoulder on the same side before.I am scheduled for a repeat joint replacement surgery.I am a female.
Research Study Groups:
This trial has the following groups:- Group 1: Electrocautery-incision and BPO group
- Group 2: Electrocautery-incision alone group
Awards:
This trial has 3 awards, including:- 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.
- 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 hazards do Electrocautery-incision and BPO group procedures pose?
"The safety of the Electrocautery-incision and BPO group has been validated by a Phase 4 trial, so it was given a rating of 3."
Answered by AI
Is the recruitment phase of this clinical trial still open?
"As per the information on clinicaltrials.gov, this trial is not recruiting patients at present. Although it was initially posted on May 1st 2023 and updated lastly in January 6th 2023; fortunately, there are 7 other medical studies actively enrolling participants currently."
Answered by AI
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