Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

Conditions

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

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Prontosan Wound Gel — DEVICE
  Applied to dermal layer of skin after incision is made for surgery.

Study Details

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.

Key Dates

Start date

Feb 23, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

Number of positive cultures [ Time Frame: 14 days ]

Central Contacts

• Randall Otto, MD
  314-617-2970
  [email protected]
• Allison Gruender, RN, MSN
  314-617-3406
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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