CompletedPhase 4

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty

United States60 participantsStarted 2023-06-26

Plain-language summary

Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is planned to undergo elective primary anatomic or reverse shoulder arthroplasty. Exclusion Criteria: * Patient is undergoing revision shoulder replacement surgery. * Patient has a known allergy to iodine, benzalkonium chloride, or polythylene glycol.

What they're measuring

Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep

Timeframe: Day 14

Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep

Timeframe: Day 14

Trial details

NCT IDNCT05919888

SponsorSt. Louis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-14

Results submitted2024-10-17

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