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NCT Number: NCT06464770

Optimizing Infection Prophylaxis Prior to Shoulder Surgery

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.

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Key information

Conditions

Arthroplasty Shoulder Periprosthetic Joint Infection

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

Location status: Recruiting

Location contact

Anastasia Whitson, BSPH

CONTACT

[email protected]

206-755-7847

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate

Drug

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 outcomes

  1. Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Dermal Pressure

    Time frame: 60 Minutes After ChloraPrep Wash

  2. Number of Quadrants on Culture Plate of Cutibacterium Growth After ChloraPrep Application with Subdermal Pressure

    Time frame: 60 Minutes After ChloraPrep Wash

Study contacts

Contact information is provided by the study sponsor or research team.

Anastasia Whitson

CONTACT

[email protected]

206-755-7847

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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