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Prosthetic-joint InfectionPhase 4NCT05676411

Benzoyl Peroxide and Electrocautery Skin Incision to Eradicate Cutibacterium Acnes

A Phase 4 study testing Benzoyl Peroxide Topical and Electrocautery surgical skin incision in people with Prosthetic-joint Infection, run by University of Missouri-Columbia at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prosthetic-joint Infection
What is being tested?
Benzoyl Peroxide Topical and Electrocautery surgical skin incision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2024to 30 Aug 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri

    Columbia, Missouri, 65212

Other trials in United States

About this study

Official title: Efficacy of Combination of Topical Benzoyl Peroxide and Electrocautery Skin Incision in Eradicating Cutibacterium Acnes From Surgical Wounds During Shoulder Arthroplasty

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:

Read more
  • 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.

Read the 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.

Being tested
Benzoyl Peroxide Topical, Electrocautery surgical skin incision
Keywords
Shoulder arthroplasty, Prosthetic joint infection, Cutibacterium acnes, Benzoyl peroxide, Electrocautery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Benzoyl Peroxide TopicalDrug

    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 surgical skin incisionProcedure or surgery

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

Study groups in NCT05676411
Study groupRoleWhat they receive
Electrocautery-incision alone groupActive comparatorThe skin inicsion will be made using electrocautery during shoulder replacement in patients assigned this group with no other preoperative treatment.
Receives: Procedure: Electrocautery surgical skin incision
Electrocautery-incision and BPO groupExperimentalPatients 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.
Receives: Drug: Benzoyl Peroxide Topical; Procedure: Electrocautery surgical skin incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within 14 days of shoulder replacement surgery

Secondary outcomes (1)
  1. Mid-procedure synovium C. acnes culture rates

    Positive C. acnes culture rates from samples taken from the synovium during the middle of the shoulder replacement

    Measured: Within 14 days of shoulder replacement surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion30 Aug 2025 (estimated)

Why it stopped: Not enough funding to conduct the project

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05676411
Sponsor's protocol ID
2095111
Status last verified
Jul 2024
First submitted
22 Dec 2022
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual patients' deidentified demographic information (age and sex only) and microbiology culture results can be shared with other researchers upon request

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Benzoyl Peroxide Topical and Electrocautery surgical skin incision in people with Prosthetic-joint Infection, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late dermis C. acnes culture rates (time frame: Within 14 days of shoulder replacement surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.

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