Reduction of Bacterial Seeding in Total Shoulder Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prontosan Wound Gel.
- Who it may be relevant to
- Registry conditions: Joint Arthroplasty, Shoulder, Cutibacterium Acnes, Prosthetic Joint Infection. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients
Overview
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.
Detailed 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.
Interventions
- Device Prontosan Wound Gel
Applied to dermal layer of skin after incision is made for surgery.
Primary outcome measures
- Number of positive cultures [Time frame: 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Saint Louis University — St Louis
Identifiers
NCT: NCT07406893 · Study00000436