Benzoyl Peroxide and Electrocautery Skin Incision to Eradicate Cutibacterium Acnes

NCT05676411 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2095111
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic-joint Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Late dermis C. acnes culture rates

  Positive C. acnes culture rates from samples taken from the incised dermis during the later part of shoulder replacement

  Within 14 days of shoulder replacement surgery

Secondary Outcomes (1)

• Mid-procedure synovium C. acnes culture rates

  Within 14 days of shoulder replacement surgery

Study Arms (2)

Electrocautery-incision alone group

ACTIVE COMPARATOR

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

Electrocautery-incision and BPO group

EXPERIMENTAL

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; Procedure: Electrocautery surgical skin incision

Interventions

Benzoyl Peroxide Topical DRUG

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.

Electrocautery-incision and BPO group

Electrocautery surgical skin incision PROCEDURE

The skin incision will be made entirely using electrocautery at the beginning of shoulder replacement.

Electrocautery-incision alone group; Electrocautery-incision and BPO group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Interventions

Benzoyl Peroxide

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hyunmin M Kim, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: June 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From May 2023 to May 2025

Locations

US (1)