Benzoyl Peroxide Gel for Total Hip Arthroplasty

Overseen By Roseann Johnson, BS CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Colorado Joint Replacement

Must not be taking: Antibiotics

Disqualifiers: Hip infection, Immunodeficiency, Psoriatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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. ^{1 2 3 4 5}

Why 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. ^{1 4 6 7 8}

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

I have a natural hip joint and am volunteering for research on knee or hip replacement.

CJR primary joint arthroplasty patients who are receiving care at Porter Adventist Hospital

I have not had joint replacement surgery before and am a patient at this practice.

Exclusion Criteria

I have had a hip infection in the past.

I have active psoriasis or inflammation over my hip.

I have had a total hip replacement surgery on both sides.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo skin cleansing protocols and skin biopsies are performed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for Propionibacterium colonization rate on hips

2 weeks

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?

Group I: Experimental Skin Prep with BPO Experimental Treatment 1 Intervention

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.

Group II: Standard Skin Prep Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Colorado Joint Replacement

Lead Sponsor

Trials

13

Recruited

3,300+

Citations

1. withpower.com withpower.com/trial/phase-4-osteoarthritis-1-2019-59270

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.

2. researchgate.net researchgate.net/publication/51800875_Allergic_complications_from_orthopaedic_joint_implants_The_role_of_delayed_hypersensitivity_to_benzoyl_peroxide_in_bone_cement

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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274622006644

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9240379/

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: ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540305000422

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).

6. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2023.1015490/full

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, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274618301198

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.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/496587/

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 ...