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Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

NCT07406893 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-10

No results posted yet for this study

Summary

The purpose of this study is to compare the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus Prontosan wound gel applied to the skin layer after the skin incision has been made.

Conditions

  • Joint Arthroplasty
  • Shoulder
  • Cutibacterium Acnes
  • Prosthetic Joint Infection

Interventions

DEVICE

Prontosan Wound Gel

Applied to dermal layer of skin after incision is made for surgery.

Sponsors & Collaborators

  • Innovice, LLC

    collaborator UNKNOWN

  • American Shoulder and Elbow Surgeons

    collaborator OTHER

  • St. Louis University

    lead OTHER

Principal Investigators

  • Randall Otto, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-23
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07406893 on ClinicalTrials.gov