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| Name | Class |
|---|---|
| Innovice, LLC | UNKNOWN |
| American Shoulder and Elbow Surgeons | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No skin incision preparation | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prontosan Wound Gel | Device | Applied to dermal layer of skin after incision is made for surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of positive cultures | 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Randall Otto, MD | Contact | 314-617-2970 | randy.otto@health.slu.edu | |
| Allison Gruender, RN, MSN | Contact | 314-617-3406 | allison.gruender@health.slu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Randall Otto, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis University | Recruiting | St Louis | Missouri | 63110 | United States |
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This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
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