Benzoyl Peroxide Gel for Total Hip Arthroplasty
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a benzoyl peroxide gel to determine if it reduces the growth of Propionibacterium acnes on the skin during hip surgery. This bacterium, often linked to acne, might affect surgery outcomes, and researchers aim to learn more about it. Participants will use either a standard skin cleaning method or one that includes the benzoyl peroxide gel. Individuals who have not had a hip replacement on the biopsy side and are undergoing hip or knee surgery might be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using antibiotics or have used them in the past week.
What is the safety track record for benzoyl peroxide gel?
Research shows that benzoyl peroxide gel is usually safe for skin application. Studies have found that it significantly reduces P. acnes, the bacteria causing acne, on the skin after surgical preparation. This indicates the gel's effectiveness in reducing skin bacteria.
However, some individuals have reported allergic reactions to benzoyl peroxide. In rare cases, these reactions can be delayed and cause issues like joint pain. For instance, a 62-year-old man experienced problems with his hip replacement due to an allergy to benzoyl peroxide.
Overall, benzoyl peroxide gel is considered safe for most people, but those with known allergies should exercise caution. If concerned about allergies, consult a doctor before deciding to join a trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using benzoyl peroxide (BPO) gel in total hip arthroplasty because it offers a new approach to pre-surgical skin preparation. While standard skin prep involves cleansing with 4% chlorhexidine gluconate (CHG), this protocol adds a 5% BPO gel application. Benzoyl peroxide is known for its antibacterial properties, which may help reduce the risk of surgical site infections more effectively than CHG alone. By potentially enhancing the antiseptic effect, this method could improve patient outcomes following hip surgery.
What evidence suggests that benzoyl peroxide gel is effective for reducing Propionibacterium colonization in hip surgery?
Research has shown that benzoyl peroxide gel can reduce certain bacteria, such as C. acnes, which can cause infections during surgeries. In past studies, using benzoyl peroxide before surgeries, like shoulder operations, decreased these bacteria. This trial will compare two skin preparation methods for hip surgeries: one using standard skin prep with 4% Chlorhexidine gluconate (CHG) cloths, and another using an experimental skin prep that includes 5% benzoyl peroxide gel following CHG wipes. Benzoyl peroxide releases oxygen, which helps kill bacteria, making it useful for preventing infections. This treatment proved effective in similar surgeries, supporting its use in hip replacements.14678
Who Is on the Research Team?
Jason M Jennings, MD DPT
Principal Investigator
Colorado Joint Replacement
Are You a Good Fit for This Trial?
This trial is for patients aged 18-85 who are undergoing primary hip or knee replacement at Porter Adventist Hospital without a previous joint replacement on the biopsy side. They must not have had a hip infection, be using antibiotics recently, have active psoriatic disease over the hip, Cutibacterium joint infections, or any immunodeficiency diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo skin cleansing protocols and skin biopsies are performed
Follow-up
Participants are monitored for Propionibacterium colonization rate on hips
What Are the Treatments Tested in This Trial?
Interventions
- Benzoyl peroxide gel
Trial Overview
The study tests Benzoyl peroxide gel's effect on reducing colonization of P acnes bacteria in the skin around the hip area. This bacterium is commonly associated with acne but its role in affecting outcomes after total hip arthroplasty (hip replacement surgery) is unknown.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths. Following the CHG wipes, patients will be prepped with 5% BPO gel applied directly to the biopsy site. After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject.
Patients will undergo a skin cleansing protocols using 4% Chlorhexidine gluconate (CHG) cloths. After the skin prep, three 3-mm punch (Acu-Punch, Acuderm, Fort Lauderdale, FL) skin biopsies will performed for both an anterior-based hypothetical incision, and for a more lateral/posterior incision, for a total of 6 biopsies taken per subject.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colorado Joint Replacement
Lead Sponsor
Citations
Benzoyl Peroxide Gel for Total Hip Arthroplasty
What is the purpose of this trial? This trial investigates how quickly a bacteria known for causing acne grows in patients who have had hip replacement surgery.
The role of delayed hypersensitivity to benzoyl peroxide in ...
In 4 patients sensitized to benzoyl peroxide, a bone cement-free replacement resulted in a considerable decrease or disappearance of pain and ...
Preoperative topical benzoyl peroxide treatment is effective ...
The aim of this systematic review is to review the effectiveness of topical BPO preoperatively in shoulder surgery in reducing C acnes colonization and ...
The role of hydrogen peroxide in hip arthroplasty
Other purported roles of hydrogen peroxide include the reduction of the most common late complication after cemented joint replacement surgery: ...
Effects of Hydrogen Peroxide Solutions on Artificial Hip ...
This study was designed to elucidate the erosive effect of hydrogen peroxide solutions on the materials used for total-hip arthroplasty (THA).
The safety and efficiency of benzoyl peroxide for reducing ...
The incidence of shoulder joint infection was approximately 0.9%–1.8%, 3%–4%, and 0.01%–0.3% for primary arthroplasty, revision arthroplasty, ...
Topical benzoyl peroxide application on the shoulder ...
Topical treatment with BPO significantly reduced the presence of P acnes measured as the number of colony-forming units on the skin after surgical preparation.
Loosening of a total hip prosthesis at contact allergy due to ...
It is reported that a 62-year-old man with total hip prosthesis developed a recurrent sterile fistula and loosening of his prosthesis due to allergy to the ...
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