Recruiting

Prontosan

Sponsor:

St. Louis University

Code:

NCT07406893

Conditions

Joint Arthroplasty

Shoulder

Cutibacterium Acnes

Prosthetic Joint Infection

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prontosan Wound Gel

Study Details

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

Study ID

NCT07406893

Start date

Feb 23, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: No skin incision preparation

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.

experimental: Prontosan Wound Gel

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.

Interventions

Prontosan Wound Gel

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

Primary outcome measure

  • Number of positive cultures [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Randall Otto, MD

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

Allison Gruender, RN, MSN

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

Locations

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Randall Otto, MD

314-617-2970

Allison Gruender, RN, MSN

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

More Information

Sponsor

St. Louis University

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Keywords

  • Antimicrobial wound gel
  • Dermal layer
  • Skin preparation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Louis University on 2026-03-10.