Cutibacterium Acnes, Joint Arthroplasty, Prosthetic Joint Infection, Shoulder
Conditions
Keywords
Antimicrobial wound gel, Dermal layer, Skin preparation
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.
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
DEVICEProntosan Wound Gel
Applied to dermal layer of skin after incision is made for surgery.
Sponsors
St. Louis University
Innovice, LLC
American Shoulder and Elbow Surgeons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of positive cultures | 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. |
Countries
United States
Contacts
CONTACTRandall Otto, MD
CONTACTAllison Gruender, RN, MSN
PRINCIPAL_INVESTIGATORRandall Otto, MD
St. Louis University
Outcome results
None listed