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Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. The Iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane.
This study examines the use of Povidone-Iodine during primary shoulder arthroplasty.
The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Shoulder Arthroplasty washed with Saline | Active Comparator | This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components |
|
| Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine) | Active Comparator | This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sterile saline solution | Drug | The shoulder will be washed with normal sterile saline before and after placing the shoulder implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction or elimination of bacteria | To determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty participants will be followed to watch for clinical signs of infection. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Surgiphor | Drug | The shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant |
|
| Sample Collection | Procedure | During the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure |
|