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

496 Participants Needed

What You Need to Know Before You Apply

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 goal is to see if this bacteria might be causing infections after the surgery.

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.

Is benzoyl peroxide gel safe for use in humans?

Benzoyl peroxide gel is generally safe for use in humans, but it can cause skin irritation and allergic reactions in some people. In studies, most adverse events were mild or moderate, and serious reactions were rare, with a reporting rate of under 1% over 20 years of use. ^{1 2 3 4 5}

How does benzoyl peroxide gel differ from other treatments for total hip arthroplasty?

Benzoyl peroxide gel is unique in the context of total hip arthroplasty because it is typically known as a component of bone cement, which can cause allergic reactions leading to complications like implant loosening. This differs from other treatments that focus on preventing infections or enhancing bone integration without the risk of such allergies. ^{6 7 8 9 10}

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. United States pubmed.ncbi.nlm.nih.gov

Benzoyl peroxide stability in pharmaceutical gel preparations. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Contact sensitization to benzoyl peroxide. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse-Event Reports in Over-the-Counter Topical Acne Drug Products Containing Benzoyl Peroxide from a Specific Pharmaceutical Company in the USA. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Post-therapeutic benzoyl peroxide contact allergy in ulcus cruris patients]. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

Loosening of a total hip prosthesis at contact allergy due to benzoyl peroxide. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Hydrogen peroxide as an irrigation solution in arthroplasty - a potential contributing factor to the development of aseptic loosening. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

[Association between allergy to benzoyl peroxide, vitiligo and implantation of a cemented total knee joint prosthesis: Is there a connection?]. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Antibiotic-Loaded Hydrogel Coating to Reduce Early Postsurgical Infections in Aseptic Hip Revision Surgery: A Retrospective, Matched Case-Control Study. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Benzoyl peroxide: is it a relevant bone cement allergen in patients with orthopaedic implants? [2013]