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.
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.
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.
- Conditions
- Prosthetic-joint Infection
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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.
- First posted9 Jan 2023
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Why it stopped: Not enough funding to conduct the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Mike Kim, University of Missouri-Columbia
- Investigators
- Hyunmin M Kim, MD, Principal investigator, University of Missouri-Columbia
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination of Topical Benzoyl Peroxide and Electrocautery Skin Incision in Eradicating Cutibacterium Acnes From Surgical Wounds During Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT05676411
- Acronym / sponsor ID
- 2095111
- Conditions
- Prosthetic-joint Infection
- Keywords
- Shoulder arthroplasty, Prosthetic joint infection, Cutibacterium acnes, Benzoyl peroxide, Electrocautery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough funding to conduct the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery-incision alone group | Active comparator | Procedure: Electrocautery surgical skin incisionThe skin inicsion will be made using electrocautery during shoulder replacement in patients assigned this group with no other preoperative treatment. |
| Electrocautery-incision and BPO group | Experimental | Drug: Benzoyl Peroxide Topical, Procedure: Electrocautery surgical skin incisionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzoyl Peroxide TopicalTopical 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. | Drug | Electrocautery-incision and BPO group |
| Electrocautery surgical skin incisionThe skin incision will be made entirely using electrocautery at the beginning of shoulder replacement. | Procedure or surgery | Electrocautery-incision alone group, Electrocautery-incision and BPO group |
Primary outcome
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
1 secondary outcome
Mid-procedure synovium C. acnes culture rates
Time frame: Within 14 days of shoulder replacement surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual patients' deidentified demographic information (age and sex only) and microbiology culture results can be shared with other researchers upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyunmin M Kim, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
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.