Arthroplasty ShoulderNCT06464770
Optimizing Infection Prophylaxis Prior to Shoulder Surgery
A study testing Chlorhexidine Gluconate in people with Arthroplasty Shoulder and Periprosthetic Joint Infection, run by University of Washington at 1 site in United States.
Trial summary
The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty Shoulder, Periprosthetic Joint Infection
- What is being tested?
- Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2024to 31 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 to 89 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
Who cannot join
- Self report very sensitive skin
- Allergic to chlorhexidine
- Used antibiotics in the last three months
- Used acne treatment in the last three months
- Wounds on your shoulders
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
University of Washington
Seattle, Washington, 98105
Anastasia Whitson, BSPH, 206-755-7847, whitsa@uw.edu
About this study
The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is:
Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different.
Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.
- Being tested
- Chlorhexidine Gluconate
- Keywords
- periprosthetic joint infection, cutibacterium, shoulder arthroplasty, chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Test Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at lower pressure (similar to a gentle wipe) for 30 seconds Control Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at higher pressure (similar to a massage) for 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Randomization Option 1 | Experimental | Right shoulder, Test Group ; Left shoulder, Control Group Receives: Drug: Chlorhexidine Gluconate |
| Randomization Option 2 | Experimental | Right shoulder, Control Group ; Left shoulder, Test Group Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure
Measured: 60 Minutes After ChloraPrep Wash
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure
Measured: 60 Minutes After ChloraPrep Wash
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start31 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ShoulderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomization Option 1: Right shoulder, Test Group ; Left shoulder, Control Group Randomization Option 2: Right shoulder, Control Group ; Left shoulder, Test Group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Hsu, University of Washington
- Investigators
- Jason Hsu, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464770
- Sponsor's protocol ID
- STUDY00020250
- Status last verified
- Dec 2024
- First submitted
- 12 Jun 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Infection Prophylaxis Prior to Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06464770
- Acronym / sponsor ID
- STUDY00020250
- Keywords
- periprosthetic joint infection, cutibacterium, shoulder arthroplasty, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jun 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.
The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is:
Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different.
Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization Option 1: Right shoulder, Test Group ; Left shoulder, Control Group Randomization Option 2: Right shoulder, Control Group ; Left shoulder, Test Group
| Arm | Type | Receives |
|---|---|---|
| Randomization Option 1 | Experimental | Drug: Chlorhexidine GluconateRight shoulder, Test Group ; Left shoulder, Control Group |
| Randomization Option 2 | Experimental | Drug: Chlorhexidine GluconateRight shoulder, Control Group ; Left shoulder, Test Group |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English speaking
Key exclusion criteria (5 listed)
- Self report very sensitive skin
- Allergic to chlorhexidine
- Used antibiotics in the last three months
- Used acne treatment in the last three months
- Wounds on your shoulders
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 |
|---|---|---|
| Chlorhexidine GluconateTest Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at lower pressure (similar to a gentle wipe) for 30 seconds Control Group: the participant's shoulder skin will be treated by the study team with the standard chlorhexidine wash at higher pressure (similar to a massage) for 30 seconds | Drug | Randomization Option 1, Randomization Option 2 |
Primary outcome
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure
Time frame: 60 Minutes After ChloraPrep Wash
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure
Time frame: 60 Minutes After ChloraPrep Wash
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 5 Dec 2024.
- 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.
Jason Hsu, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Gluconate in people with Arthroplasty Shoulder and Periprosthetic Joint Infection, run by University of Washington 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 5 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 5 Dec 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.
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 Anastasia Whitson (206-755-7847, whitsa@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure (time frame: 60 Minutes After ChloraPrep Wash). The study lists 2 primary outcomes in all. 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 Dec 2024.