Benzoyl Peroxide and Electrocautery Skin Inicision to Eradicate Cutibacterium Acnes

• ClinicalTrials.gov Identifier: NCT05676411
• Recruitment Status: Not yet recruiting
• First Posted: January 9, 2023
• Last Update Posted: January 10, 2023
• Sponsor: University of Missouri-Columbia
• Information provided by (Responsible Party): H. Mike Kim, University of Missouri-Columbia

Study Description

Brief Summary:

The goal of this prospective randomized clinical trial is to investigate the potential synergistic effect of combination of topical benzoyl peroxide and making skin incision with electrocautery on preventing surgical wound contamination from Cutibacterium acnes (C. acnes) in patients undergoing shoulder replacement.

The main question it aims to answer is:

• Will the combined use of topical application of benzoyl peroxide and making skin incision using electrocautery decrease the positive culture rates of C. acnes in the surgical field?

Participants will be asked to apply topical benzoyl peroxide to the shoulder skin prior to their shoulder replacement surgery if they are randomized in the treatment group. The skin incision will be made using electrocautery in both the control and treatment groups. Microbiology swab cultures will be taken during shoulder replacement surgery to compare the positive culture rates for C. acnes between the groups.

Condition or disease	Intervention/treatment	Phase
Prosthetic-joint Infection	Drug: Benzoyl Peroxide Topical; Procedure: Electrocautery surgical skin incision	Phase 4

Detailed Description:

Periprosthetic joint infection (PJI) following shoulder arthroplasty is not only detrimental to patients but also immensely burdensome on our healthcare system. The rate of PJI following shoulder arthroplasty is estimated between 0.80 and 1.46%, with the incidence expected to increase as shoulder arthroplasty continues to become more common. Cutibacterium acnes (C. acnes), a gram-positive anaerobe commonly found in sebaceous glands, is the most common causative organism behind PJI of shoulder arthroplasty. The human shoulder skin is heavily colonized with C. acnes, and studies showed that the current standard sterilization practices are not able to completely remove C. acnes from the surgical field. It is theorized that when skin incisions are made, the sebaceous glands in the skin are also cut open, releasing C. acnes and contaminating gloves, instruments, and eventually the surgical field during subsequent part of the procedure. Preventing C. acnes contamination could potentially decrease PJI significantly after shoulder arthroplasty.

Electrocautery has been routinely used for tissue dissection and hemostasis. Studies have demonstrated the safety and efficacy of electrocautery for making skin incisions as an alternative to a scalpel blade. It is hypothesized that the high temperatures generated at the tip of an electrocautery electrode might potentially heat up and destroy the exposed C. acnes at the incised dermal edge. This hypothesis has been recently proven in a randomized clinical trial conducted at the investigators' institution. Cultures taken from the incised dermal edge immediately after making skin incision with electrocautery resulted in zero positive C. acnes culture compared to a 31% positive culture rate observed with incisions made with scalpel blades. Although it appeared that electrocautery initially eliminated C. acnes from the incision sites, cultures taken from surgeon's gloves and instruments towards the end of the case were found to be positive for C. acnes. All positive cultures were exclusively from male patients. It remains to be answered whether the benefits of electrocautery are only temporary or if the skin surrounding the incision site remains a source for potential contaminant bacteria that current skin prep methods are unable to address.

Topical benzoyl peroxide (BPO) has been widely used as an agent for acne vulgaris, also caused by the same C. acnes bacterium. Studies have investigated the benefits of topical BPO application before open shoulder procedures in reducing C. acnes colonization at the surgical site skin. Compared to conventional skin prep methods, the addition of BPO was found to be significantly more effective in reducing C. acnes from the skin. Based on this finding, it seems to be an interesting yet logical hypothesis that combining topical BPO with electrocautery skin incision might have a synergistic effect against C. acnes. However, no studies to date have sought to examine this hypothesis. To this end, the investigators propose a prospective randomized clinical trial to test this hypothesis through the following specific aim.

Specific Aim: To investigate whether a topical BPO skin prep combined with electrocautery skin incision will lead to a critical reduction of positive C. acnes culture rates in the surgical field compared to electrocautery skin incision alone in shoulder arthroplasty patients.

Methods: Sixty-four male patients (based on a priori sample size calculation) undergoing primary shoulder arthroplasty will be randomized into 2 groups - electrocautery incision alone vs. electrocautery incision combined with BPO skin prep. The investigators will obtain a swab culture for C. acnes from the incised dermal edge immediately after skin incision, and then toward the end of procedure (immediately before humeral component insertion), the investigators will obtain another set of cultures from the incised dermal edge, surgeon's gloves, and joint synovium. The primary outcome measure will be the positive culture rates for C. acnes compared between the 2 groups.

Hypothesis: Compared to the electrocautery incision alone group, the group that receives electrocautery incision combined with BPO skin prep will yield significantly lower positive culture rates for C. acnes in the samples taken later during the procedure, but not in the samples taken from the dermal edge immediately after skin incision.

Expected outcomes and impact: It is expected that the combination of electrocautery skin incision and BPO will lead to a significant reduction of C. acnes positive culture rates in the surgical field. This study, if supported by the study finding, could potentially help understand the underlying mechanism of unexpected positive C. acnes cultures in shoulder arthroplasty and may provide a cost-effective solution for this common clinical problem.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Combination of Topical Benzoyl Peroxide and Electrocautery Skin Incision in Eradicating Cutibacterium Acnes From Surgical Wounds During Shoulder Arthroplasty
• Estimated Study Start Date: May 1, 2023
• Estimated Primary Completion Date: May 30, 2024
• Estimated Study Completion Date: August 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Electrocautery-incision alone group; The skin inicsion will be made using electrocautery during shoulder replacement in patients assigned this group with no other preoperative treatment.	Procedure: Electrocautery surgical skin incision; The skin incision will be made entirely using electrocautery at the beginning of shoulder replacement.
Experimental: Electrocautery-incision and BPO group; 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.	Drug: Benzoyl Peroxide Topical; Topical benzoyl peroxide cream will be applied to the shoulder skin twice a day for 2 days leading up to and in the morning of surgery.; Procedure: Electrocautery surgical skin incision; The skin incision will be made entirely using electrocautery at the beginning of shoulder replacement.

Outcome Measures

Primary Outcome Measures :

1. Late dermis C. acnes culture rates [ Time Frame: Within 14 days of shoulder replacement surgery ]
   Positive C. acnes culture rates from samples taken from the incised dermis during the later part of shoulder replacement

Secondary Outcome Measures :

1. Mid-procedure synovium C. acnes culture rates [ Time Frame: Within 14 days of shoulder replacement surgery ]
   Positive C. acnes culture rates from samples taken from the synovium during the middle of the shoulder replacement

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adult male patients (>18 years old) who will undergo primary shoulder arthroplasty (either anatomic or reverse) secondary to osteoarthritis, cuff tear arthropathy, or massive irreparable rotator cuff tear.

Exclusion Criteria:

• History of ipsilateral open shoulder procedures
• History of ipsilateral shoulder infection (either native or postoperative infection)
• Intake of any preoperative antibiotics within one month prior to index surgery
• Active acne at surgical site
• History of psoriatic or eczematous lesions to the surrounding shoulder region
• History of allergic reactions to benzoyl peroxide
• Planned for revision arthroplasty surgery
• Minors under the age of 18 years old
• Female patients
• Prisoners
• Workers compensation insurance status
• Surgery planned for acute proximal humerus fracture or fracture sequelae (nonunion or malunion)
• Patients who cannot understand English well enough to adequately provide informed consent.

Contacts and Locations

Contacts

Contact: Hyunmin M Kim, MD; 3149203263; kimhm@health.missouri.edu

Locations

United States, Missouri

University of Missouri

Columbia, Missouri, United States, 65212

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

• Principal Investigator: Hyunmin M Kim, MD; University of Missouri-Columbia

More Information

• Responsible Party: H. Mike Kim, Associate Professor, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT05676411
• Other Study ID Numbers: MU3341567
• First Posted: January 9, 2023
• Last Update Posted: January 10, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual patients' deidentified demographic information (age and sex only) and microbiology culture results can be shared with other researchers upon request
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: From May 2023 to May 2025

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by H. Mike Kim, University of Missouri-Columbia:

Shoulder arthroplasty; Prosthetic joint infection; Cutibacterium acnes; Benzoyl peroxide; Electrocautery

Additional relevant MeSH terms:

Benzoyl Peroxide; Dermatologic Agents