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NCT Number: NCT07406893

Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Allison Gruender, RN, MSN

CONTACT

[email protected]

314-617-3406

Randall Otto, MD

CONTACT

314-617-2970

About this study

60 male patients undergoing primary anatomic or reverse shoulder arthroplasty will be enrolled in this prospective, randomized controlled trial evaluating the use of Prontosan wound gel versus no preparation to the dermal layer of skin after incision has been made. Participants will be randomly assigned to one of two groups of 30 patients: control (no post-incision dermal preparation) and Prontosan antimicrobial gel application to the dermal layer after skin incision. All patients, regardless of assignment, receive the same pre-incision skin preparations, prophylactic antibiotics, and intraoperative irrigation. After final implantation and before wound closure, culture swabs will be obtained (2 deep cultures, 2 superficial, and 1 implant). All cultures will be held in the lab for 2 weeks to monitor for growth of C. acnes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prontosan Wound Gel

Device

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

Primary outcomes

  1. Number of positive cultures

    Time frame: 14 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Gruender, RN, MSN

CONTACT

[email protected]

314-617-3406

Randall Otto, MD

CONTACT

[email protected]

314-617-2970

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Collaborators

  • American Shoulder and Elbow Surgeons
  • Innovice, LLC

Registry information

Official study title

Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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