Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

NCT07406893 | Recruiting FDA Device

• 1 other identifier: Study00000436
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Antimicrobial wound gel; Dermal layer; Skin preparation

Outcome Measures

Primary Outcomes (1)

• Number of positive cultures

  Each participant will have culture swabs taken at the end of the surgical case from deep, superficial, and implant locations. Cultures will be held in the lab for 2 weeks to evaluate for the presence of bacteria.

  14 days

Study Arms (2)

No skin incision preparation

NO INTERVENTION

All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will not be prepped with any additional agents for patients in this arm.

Prontosan Wound Gel

EXPERIMENTAL

All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will be prepped with Prontosan Wound Gel for patients in this arm. Prontosan Wound gel is an antimicrobial gel agent intended to keep wounds free of bacteria.

Device: Prontosan Wound Gel

Interventions

Prontosan Wound Gel DEVICE

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

Prontosan Wound Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male 18 years of age or older undergoing elective primary total shoulder arthroplasty, including both anatomic and reverse total shoulder arthroplasty, for indications including massive rotator cuffs, rotator cuff arthropathy, glenohumeral osteoarthritis, and acute fractures.

You may not qualify if:

• Any revision shoulder arthroplasty procedure or other shoulder surgery that is not a primary shoulder arthroplasty.
• Patients with allergy to active ingredients in Prontosan gel
• Patient is unable to consent for themselves
• Patient is non-English speaking
• Females

Sponsors & Collaborators

• St. Louis University: lead
• Innovice, LLC: collaborator
• American Shoulder and Elbow Surgeons: collaborator

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

RECRUITING

Study Officials

• Randall Otto, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randall Otto, MD

CONTACT

314-617-2970; randy.otto@health.slu.edu

Allison Gruender, RN, MSN

CONTACT

314-617-3406; allison.gruender@health.slu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)