Shoulder ArthroplastyNCT06831422
Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
A study testing Povidone-Iodine, Hydrogen Peroxide and Xperience Antimicrobial Wash in people with Shoulder Arthroplasty and Positive C. Acnes Culture, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroplasty, Positive C. Acnes Culture
- What is being tested?
- Povidone-Iodine, Hydrogen Peroxide and Xperience Antimicrobial Wash
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated and scheduled for primary shoulder arthroplasty.
- Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy,
- Ability to read and understand English
- Age ≥18 years
- Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS)
Who cannot join
- Patient with history of prior native shoulder septic arthritis or infection
- Prior surgery of affected shoulder
- Proximal Humerus Fracture
- Active infection
- Cancer
- Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
- History of allergic reaction to citric acid-derived products
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Chimdindu Obinero, BS, 678-230-8592, cobiner1@hfhs.org
Jared Mahylis, MD, 313-916-2181, jmahyli1@hfhs.org
About this study
Official title: Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Dermis and Incidence of Cutibacterium Acnes During Shoulder Arthroplasty: A Randomized Controlled Trial
The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments:
- Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL)
- Post-incision application of 3% hydrogen peroxide
- Post-incision application of 10% povidone-iodine (betadine)
- No post-incision treatment (control)
The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.
Read the detailed description
Cultures will be collected from the following sites:
- The surgical site prior to the initial incision
- The incision site after the initial incision
- The shoulder joint
- The room air
Cultures will be monitored daily for the presence of C. Acnes up to 18 days post-surgery. At postoperative clinic visits, patients in all groups will undergo a clinical evaluation by their surgeon, which includes assessment of wound healing and any complications at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery. A password-secured database and data points will be pulled from electronic medical records. Data will be analyzed and will be utilized to come to the conclusion of the study.
- Conditions
- Shoulder Arthroplasty, Positive C. Acnes Culture
- Being tested
- Povidone-Iodine, Hydrogen Peroxide, Xperience Antimicrobial Wash, Bacterial Cultures, Shoulder Arthroplasty
- Keywords
- Shoulder Arthroplasty, Antimicrobial, Post-incision wash, C. Acnes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDevice
Following electrocautery opening of the dermal layer, patients in the povidine-iodine group (Group B) will receive application of 10% sterile povidone-iodine along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of betadine, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).
Hydrogen PeroxideDevice
Following electrocautery opening of the dermal layer, patients in the hydrogen peroxide group (Group A) will receive application of 3% sterile-filtered hydrogen peroxide along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of hydrogen peroxide a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).
Xperience Antimicrobial WashDevice
Following electrocautery opening of the dermal layer, patients in the patients in the Xperience group (Group C) will receive application of the Xperience antimicrobial wash (NextScience, Jacksonville, FL) (32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water) along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of Xperience, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).
Bacterial CulturesDiagnostic test
Four C. Acnes cultures will be obtained for every patient. Once the skin has dried, a culture swab will be applied along the planned incision for all patients (skin culture). Approximately 120 seconds after application of Xperience, hydrogen peroxide or betadine, or after initial incision in the case of the control group, a culture of the dermis will then taken by dragging the culture swab along the length of the exposed dermis (dermis culture). Once the glenohumeral joint is exposed, the surgeon will apply new surgical gloves, and a culture swab will be placed into the joint and along the humeral head (glenohumeral joint culture). An additional culture will then be taken from the air in the operative suite (air culture)
Shoulder ArthroplastyProcedure or surgery
All patients will undergo hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty in accordance with the appropriate indications and enrollment in this study.
| Study group | Role | What they receive |
|---|---|---|
| Xperience Antimicrobial Wash | Experimental | Xperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision. Receives: Device: Xperience Antimicrobial Wash; Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty |
| 3% hydrogen peroxide | Experimental | To be applied along the entire dermis using a soaked surgical sponge following initial incision. Receives: Device: Hydrogen Peroxide; Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty |
| 10% povidone-iodine | Experimental | To be applied along the entire dermis using a soaked surgical sponge following initial incision. Receives: Device: Povidone-Iodine; Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty |
| Control | Active comparator | No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures Receives: Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of C. Acnes
- Acnes cultures will be sampled from surgical site prior to the initial incision (skin culture), from the incision site after the initial incision (dermal culture), from the glenohumeral joint (glenohumeral joint culture), and from the room air (air culture). Each culture will be monitored for up to 18 days for growth of C. Acnes.
Measured: up to 18 days
Secondary outcomes (2)
Number and Types of Complications
Patients will be closely monitored for intraoperative and postoperative complications and any sign of adverse reactions to these solutions.
Measured: up to 1 year postop.
Number of Subjects that Require Postoperative Reoperations
Whether or not patients require another operation will be documented. The number of patients requiring postoperative reoperation will be compared between groups.
Measured: up to 1 year postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start5 May 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All groups will receive standard presurgical preparation with standard surgical skin preparation. This begins with each subject receiving two chlorhexidine scrub brushes with which they will be instructed to scrub themselves the night before and morning of their surgery. Once in the operating room, all subjects will have their surgical site treated with Chlorhexidine Gluconate 4% soap, once with 3% hydrogen peroxide, and then twice with standard operative skin preparation agent, Chloraprep (2% chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol). No preoperative acetic acid, betadine, or benzoyl peroxide will be applied to the surgical shoulder. The intervention will only take place after the initial incision has been made. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will either receive one of the wash solutions (Xperience, Povidone, or Hydrogen peroxide) or a control group that will receive no post-incision wash.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Next Science TM
- Responsible party
- Principal investigator, Jared Mahylis, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831422
- Sponsor's protocol ID
- 17996
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Dermis and Incidence of Cutibacterium Acnes During Shoulder Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06831422
- Acronym / sponsor ID
- 17996
- Conditions
- Shoulder Arthroplasty, Positive C. Acnes Culture
- Keywords
- Shoulder Arthroplasty, Antimicrobial, Post-incision wash, C. Acnes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Next Science TM
- Study start
- 5 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Feb 2025 (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 purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments:
- Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL)
- Post-incision application of 3% hydrogen peroxide
- Post-incision application of 10% povidone-iodine (betadine)
- No post-incision treatment (control)
The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.
Detailed description
Cultures will be collected from the following sites:
- The surgical site prior to the initial incision
- The incision site after the initial incision
- The shoulder joint
- The room air
Cultures will be monitored daily for the presence of C. Acnes up to 18 days post-surgery. At postoperative clinic visits, patients in all groups will undergo a clinical evaluation by their surgeon, which includes assessment of wound healing and any complications at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery. A password-secured database and data points will be pulled from electronic medical records. Data will be analyzed and will be utilized to come to the conclusion of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- All groups will receive standard presurgical preparation with standard surgical skin preparation. This begins with each subject receiving two chlorhexidine scrub brushes with which they will be instructed to scrub themselves the night before and morning of their surgery. Once in the operating room, all subjects will have their surgical site treated with Chlorhexidine Gluconate 4% soap, once with 3% hydrogen peroxide, and then twice with standard operative skin preparation agent, Chloraprep (2% chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol). No preoperative acetic acid, betadine, or benzoyl peroxide will be applied to the surgical shoulder. The intervention will only take place after the initial incision has been made. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will either receive one of the wash solutions (Xperience, Povidone, or Hydrogen peroxide) or a control group that will receive no post-incision wash.
| Arm | Type | Receives |
|---|---|---|
| Xperience Antimicrobial Wash | Experimental | Device: Xperience Antimicrobial Wash, Diagnostic Test: Bacterial Cultures, Procedure: Shoulder ArthroplastyXperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision. |
| 3% hydrogen peroxide | Experimental | Device: Hydrogen Peroxide, Diagnostic Test: Bacterial Cultures, Procedure: Shoulder ArthroplastyTo be applied along the entire dermis using a soaked surgical sponge following initial incision. |
| 10% povidone-iodine | Experimental | Device: Povidone-Iodine, Diagnostic Test: Bacterial Cultures, Procedure: Shoulder ArthroplastyTo be applied along the entire dermis using a soaked surgical sponge following initial incision. |
| Control | Active comparator | Diagnostic Test: Bacterial Cultures, Procedure: Shoulder ArthroplastyNo treatment of the dermal layer will be performed prior to a collection of the bacterial cultures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indicated and scheduled for primary shoulder arthroplasty.
- Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy,
- Ability to read and understand English
- Age ≥18 years
- Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS)
Key exclusion criteria (7 listed)
- Patient with history of prior native shoulder septic arthritis or infection
- Prior surgery of affected shoulder
- Proximal Humerus Fracture
- Active infection
- Cancer
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 |
|---|---|---|
| Povidone-IodineFollowing electrocautery opening of the dermal layer, patients in the povidine-iodine group (Group B) will receive application of 10% sterile povidone-iodine along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of betadine, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture). | Device | 10% povidone-iodine |
| Hydrogen PeroxideFollowing electrocautery opening of the dermal layer, patients in the hydrogen peroxide group (Group A) will receive application of 3% sterile-filtered hydrogen peroxide along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of hydrogen peroxide a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture). | Device | 3% hydrogen peroxide |
| Xperience Antimicrobial WashFollowing electrocautery opening of the dermal layer, patients in the patients in the Xperience group (Group C) will receive application of the Xperience antimicrobial wash (NextScience, Jacksonville, FL) (32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water) along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of Xperience, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture). | Device | Xperience Antimicrobial Wash |
| Bacterial CulturesFour C. Acnes cultures will be obtained for every patient. Once the skin has dried, a culture swab will be applied along the planned incision for all patients (skin culture). Approximately 120 seconds after application of Xperience, hydrogen peroxide or betadine, or after initial incision in the case of the control group, a culture of the dermis will then taken by dragging the culture swab along the length of the exposed dermis (dermis culture). Once the glenohumeral joint is exposed, the surgeon will apply new surgical gloves, and a culture swab will be placed into the joint and along the humeral head (glenohumeral joint culture). An additional culture will then be taken from the air in the operative suite (air culture) | Diagnostic test | 10% povidone-iodine, 3% hydrogen peroxide, Control, Xperience Antimicrobial Wash |
| Shoulder ArthroplastyAll patients will undergo hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty in accordance with the appropriate indications and enrollment in this study. | Procedure or surgery | 10% povidone-iodine, 3% hydrogen peroxide, Control, Xperience Antimicrobial Wash |
Primary outcome
Incidence of C. Acnes
Time frame: up to 18 days
C. Acnes cultures will be sampled from surgical site prior to the initial incision (skin culture), from the incision site after the initial incision (dermal culture), from the glenohumeral joint (glenohumeral joint culture), and from the room air (air culture). Each culture will be monitored for up to 18 days for growth of C. Acnes.
2 secondary outcomes
Number and Types of Complications
Time frame: up to 1 year postop.
Number of Subjects that Require Postoperative Reoperations
Time frame: up to 1 year postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine, Hydrogen Peroxide and Xperience Antimicrobial Wash in people with Shoulder Arthroplasty and Positive C. Acnes Culture, run by Henry Ford Health System 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chimdindu Obinero, BS (678-230-8592, cobiner1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of C. Acnes (time frame: up to 18 days). 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 18 Sep 2026.