Optimizing Infection Prophylaxis Prior to Shoulder Surgery

NCT06464770 | Recruiting DMC

• 1 other identifier: STUDY00020250
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

periprosthetic joint infection; cutibacterium; shoulder arthroplasty; chlorhexidine

Outcome Measures

Primary Outcomes (2)

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

  60 Minutes After ChloraPrep Wash

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

  60 Minutes After ChloraPrep Wash

Study Arms (2)

Randomization Option 1

EXPERIMENTAL

Right shoulder, Test Group ; Left shoulder, Control Group

Drug: Chlorhexidine Gluconate

Randomization Option 2

EXPERIMENTAL

Right shoulder, Control Group ; Left shoulder, Test Group

Drug: Chlorhexidine Gluconate

Interventions

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

Randomization Option 1; Randomization Option 2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Interventions

chlorhexidine gluconate

Study Officials

• Jason Hsu, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Whitson

CONTACT

206-755-7847; whitsa@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Orthopaedic Surgery and Sports Medicine

Model Details: Randomization Option 1: Right shoulder, Test Group ; Left shoulder, Control Group Randomization Option 2: Right shoulder, Control Group ; Left shoulder, Test Group

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: August 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)