Recruiting

Infection Prophylaxis

Sponsor:

University of Washington

Code:

NCT06464770

Conditions

Arthroplasty Shoulder

Periprosthetic Joint Infection

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Chlorhexidine Gluconate

Study Details

Brief 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. 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.

Conditions

Arthroplasty Shoulder

Periprosthetic Joint Infection

Study ID

NCT06464770

Start date

Aug 31, 2024

Status verified date

Dec, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • English speaking

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Randomization Option 1

Right shoulder, Test Group ; Left shoulder, Control Group

experimental: Randomization Option 2

Right shoulder, Control Group ; Left shoulder, Test Group

Interventions

Chlorhexidine Gluconate

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

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 ]
  • Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure [ Time Frame: 60 Minutes After ChloraPrep Wash ]

Central Contacts and Locations

Central contacts

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Anastasia Whitson, BSPH

206-755-7847whitsa@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Dec 5, 2024

Last verified

Dec, 2024

Keywords

  • periprosthetic joint infection
  • cutibacterium
  • shoulder arthroplasty
  • chlorhexidine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-12-05.