Cutibacterium AcnesNCT06513182
Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty?
A study testing No Alexis orthopaedic protector and Alexis orthopaedic protector in people with Cutibacterium Acnes, run by University of Utah at 1 site in United States.
Trial summary
Prosthetic joint infection is a devastating complication of shoulder arthroplasty. A relatively novel method of preventing PJI has been with the use of a wound protection device. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cutibacterium Acnes
- What is being tested?
- No Alexis orthopaedic protector and Alexis orthopaedic protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2024to 12 Mar 2026
- Phase
- Interventional
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary anatomic or reverse shoulder arthroplasty by one of three surgeons will be eligible.
Who cannot join
- revision arthroplasty,
- history of ipsilateral shoulder infection,
- patients unable or unwilling to consent,
- prisoners,
- pregnant individuals,
- mentally disabled patients,
- employees of the University of Utah,
- allergy to polyurethane polyester.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty? A Randomized Controlled Trial
Prosthetic joint infection is a devastating complication of shoulder arthroplasty. A relatively novel method of preventing PJI has been with the use of a wound protection device. There is minimal investigative research on the use of a wound protector in shoulder arthroplasty, specifically with an ability to decrease wound contamination. The investigators primary purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of bacteria in primary shoulder arthroplasty. A secondary purpose is to evaluate if the wound protector decreases soft tissue trauma during total shoulder arthroplasty.
Read the detailed description
Prosthetic joint infection (PJI) is a relatively uncommon but devastating complication of shoulder arthroplasty. Published rates of PJI after shoulder arthroplasty range one to ten percent. Since the advent of surgery, infection has been a constant battle. As a profession, we have made strides in preventing infection. Infection prevention started with the popularization of hand washing and preparation and draping of the sterile field in the nineteenth and twentieth centuries, with more recent advancements including pre-operative and intra-operative antimicrobial washes, antibiotic powders, and ultraviolent light exposure. Despite these advancement, PJI continues to be a problem in orthopaedic arthroplasty surgery, and we need to continue to improve our infection prevention techniques.
Risk factors for PJI in shoulder arthroplasty include revision surgery, obesity, male gender, younger age, and non-osteoarthritis indication for surgery. Unfortunately, the majority of these risk factors are non-modifiable and are difficult to mitigate short of avoiding surgery on these patients. Due to this, surgeons need to continue to find ways of preventing PJI both pre-operatively and intra-operatively. The most frequent bacteria responsible for shoulder PJI are cutibacterium acnes and s. epidermidis, causing an estimated 67 and 27 percent of shoulder PJIs respectively. C. acnes is difficult to prevent due to its prevalence in the sebaceous glands in the shoulder, neck, and upper back area. Published methods of preventing c. acnes infection include pre-operative antibiotics, skin preparation with hydrogen peroxide wash, betadine wash after skin incision, and many others. Most of these methods focus on destroying the bacterium that are present in the wound. The inherent problem is that c. acnes is symbiotic and lives in human skin, therefore attempting to destroy it is an uphill battle as it will continue to recolonize the wound through the operation.
A relatively novel method of preventing PJI has been with the use of a wound protection device. While there is some outcome data with the use of this device in hip arthroplasty, there is minimal data in regards to shoulder arthroplasty. The only peer-reviewed study of use of a flexible wound protector in shoulder arthroplasty demonstrated a decrease in c. acnes colonization in shoulder wounds after placement of a wound protector. The purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of c. acnes in primary shoulder arthroplasty.
PRELIMINARY STUDIES:
A study at the investigators institution looked at the use of a hydrogen peroxide skin preparation prior to shoulder arthroplasty surgery, and found that the standardized peroxide preparation decreased surgical wound colonization with c. acnes to 10 percent versus 35 percent in the control group. While the proposed study is different, the investigators intend to use a similar study protocol as this is a proven protocol that worked effectively within this institution.
- Conditions
- Cutibacterium Acnes
- Being tested
- No Alexis orthopaedic protector, Alexis orthopaedic protector
- Keywords
- Total shoulder arthroplasty, Wound protector, Cutibacterium acnes, Contamination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Alexis orthopaedic protectorOther
No Alexis orthopaedic protector will be used during the course of the surgery.
Alexis orthopaedic protectorDevice
Also called Wound protector, Rigid Retraction Ring, Flexible Retraction Ring
Alexis orthopaedic protector will be inserted after making an initial superficial approach to the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Control - no wound protector | Other | The (control - no wound protector) will not use the protector device during the course of the surgery. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis. Receives: Other: No Alexis orthopaedic protector |
| Wound protector | Experimental | Wound protector group will have an insertion of a wound protector after making an initial superficial approach to the shoulder. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis. The wound protector will then remain in place until the end of the case during wound closure. Receives: Device: Alexis orthopaedic protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive C acnes culture
The primary outcome of the study will be percent of positive C acnes culture results.
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start21 Jun 2024
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutibacterium AcnesStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Joyce, University of Utah
- Investigators
- Christopher Joyce, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513182
- Sponsor's protocol ID
- 179068
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06513182
- Acronym / sponsor ID
- 179068
- Conditions
- Cutibacterium Acnes
- Keywords
- Total shoulder arthroplasty, Wound protector, Cutibacterium acnes, Contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 22 Jul 2024 (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.
Prosthetic joint infection is a devastating complication of shoulder arthroplasty. A relatively novel method of preventing PJI has been with the use of a wound protection device. There is minimal investigative research on the use of a wound protector in shoulder arthroplasty, specifically with an ability to decrease wound contamination. The investigators primary purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of bacteria in primary shoulder arthroplasty. A secondary purpose is to evaluate if the wound protector decreases soft tissue trauma during total shoulder arthroplasty.
Detailed description
Prosthetic joint infection (PJI) is a relatively uncommon but devastating complication of shoulder arthroplasty. Published rates of PJI after shoulder arthroplasty range one to ten percent. Since the advent of surgery, infection has been a constant battle. As a profession, we have made strides in preventing infection. Infection prevention started with the popularization of hand washing and preparation and draping of the sterile field in the nineteenth and twentieth centuries, with more recent advancements including pre-operative and intra-operative antimicrobial washes, antibiotic powders, and ultraviolent light exposure. Despite these advancement, PJI continues to be a problem in orthopaedic arthroplasty surgery, and we need to continue to improve our infection prevention techniques.
Risk factors for PJI in shoulder arthroplasty include revision surgery, obesity, male gender, younger age, and non-osteoarthritis indication for surgery. Unfortunately, the majority of these risk factors are non-modifiable and are difficult to mitigate short of avoiding surgery on these patients. Due to this, surgeons need to continue to find ways of preventing PJI both pre-operatively and intra-operatively. The most frequent bacteria responsible for shoulder PJI are cutibacterium acnes and s. epidermidis, causing an estimated 67 and 27 percent of shoulder PJIs respectively. C. acnes is difficult to prevent due to its prevalence in the sebaceous glands in the shoulder, neck, and upper back area. Published methods of preventing c. acnes infection include pre-operative antibiotics, skin preparation with hydrogen peroxide wash, betadine wash after skin incision, and many others. Most of these methods focus on destroying the bacterium that are present in the wound. The inherent problem is that c. acnes is symbiotic and lives in human skin, therefore attempting to destroy it is an uphill battle as it will continue to recolonize the wound through the operation.
A relatively novel method of preventing PJI has been with the use of a wound protection device. While there is some outcome data with the use of this device in hip arthroplasty, there is minimal data in regards to shoulder arthroplasty. The only peer-reviewed study of use of a flexible wound protector in shoulder arthroplasty demonstrated a decrease in c. acnes colonization in shoulder wounds after placement of a wound protector. The purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of c. acnes in primary shoulder arthroplasty.
PRELIMINARY STUDIES:
A study at the investigators institution looked at the use of a hydrogen peroxide skin preparation prior to shoulder arthroplasty surgery, and found that the standardized peroxide preparation decreased surgical wound colonization with c. acnes to 10 percent versus 35 percent in the control group. While the proposed study is different, the investigators intend to use a similar study protocol as this is a proven protocol that worked effectively within this institution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - no wound protector | Other | Other: No Alexis orthopaedic protectorThe (control - no wound protector) will not use the protector device during the course of the surgery. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis. |
| Wound protector | Experimental | Device: Alexis orthopaedic protectorWound protector group will have an insertion of a wound protector after making an initial superficial approach to the shoulder. During surgery 4 tissue swab cultures will be obtained and sent to a laboratory for analysis. The wound protector will then remain in place until the end of the case during wound closure. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary anatomic or reverse shoulder arthroplasty by one of three surgeons will be eligible.
Key exclusion criteria (8 listed)
- revision arthroplasty,
- history of ipsilateral shoulder infection,
- patients unable or unwilling to consent,
- prisoners,
- pregnant individuals,
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 |
|---|---|---|
| No Alexis orthopaedic protectorNo Alexis orthopaedic protector will be used during the course of the surgery. | Other | Control - no wound protector |
| Alexis orthopaedic protectorAlso: Wound protector, Rigid Retraction Ring, Flexible Retraction RingAlexis orthopaedic protector will be inserted after making an initial superficial approach to the shoulder. | Device | Wound protector |
Primary outcome
Positive C acnes culture
Time frame: 2-weeks
The primary outcome of the study will be percent of positive C acnes culture results.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Christopher Joyce, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Alexis orthopaedic protector and Alexis orthopaedic protector in people with Cutibacterium Acnes, run by University of Utah 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 8 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: finished, as of the sponsor's last update on 5 Jun 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive C acnes culture (time frame: 2-weeks). 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 5 Jun 2026.