Reduction of Bacterial Seeding in Total Shoulder Arthroplasty

Saint Louis University (SLU)

Status: Enrolling

Conditions: Cutibacterium Acnes; Joint Arthroplasty; Prosthetic Joint Infection; Shoulder

Treatments: Device: Prontosan Wound Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07406893

Study00000436

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

No skin incision preparation

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Prontosan Wound Gel