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| Name | Class |
|---|---|
| Mercy Health | OTHER |
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A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes
The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiseptic Cleanser | Experimental | Standard prophylaxis will be administered by Irrisept patients as would individuals in the control group. In addition, these Irrisept study subjects will be supplemented with the use of Irrisept irrigation by the study surgeon during the patient's surgical procedure. Standard times for irrigation will include immediately after incision through the dermal layer, and immediately prior to implantation of any prosthetic components. Final irrigation will be performed just prior to closure of the deltopectoral interval. |
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| Standard of Care Prophylaxis | No Intervention | Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiseptic Cleanser | Drug | Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria. |
| Measure | Description | Time Frame |
|---|---|---|
| C.acnes Growth Rate | To compare the rate of C.acnes using two different antiseptic protocols | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)] | 6 months |
| ROM |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan | 49525 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25979553 | Background | Horneff JG 3rd, Hsu JE, Voleti PB, O'Donnell J, Huffman GR. Propionibacterium acnes infection in shoulder arthroscopy patients with postoperative pain. J Shoulder Elbow Surg. 2015 Jun;24(6):838-43. doi: 10.1016/j.jse.2015.03.008. | |
| 22981447 | Background | Levy O, Iyer S, Atoun E, Peter N, Hous N, Cash D, Musa F, Narvani AA. Propionibacterium acnes: an underestimated etiology in the pathogenesis of osteoarthritis? J Shoulder Elbow Surg. 2013 Apr;22(4):505-11. doi: 10.1016/j.jse.2012.07.007. Epub 2012 Sep 13. |
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Prospective, Randomized, Controlled Trial
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Range of Motion
| 6 Months |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) | the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures. | 6 Months |
| 24306704 | Background | Matsen FA 3rd, Butler-Wu S, Carofino BC, Jette JL, Bertelsen A, Bumgarner R. Origin of propionibacterium in surgical wounds and evidence-based approach for culturing propionibacterium from surgical sites. J Bone Joint Surg Am. 2013 Dec 4;95(23):e1811-7. doi: 10.2106/JBJS.L.01733. |
| 25547858 | Background | Matsen FA 3rd, Russ SM, Bertelsen A, Butler-Wu S, Pottinger PS. Propionibacterium can be isolated from deep cultures obtained at primary arthroplasty despite intravenous antimicrobial prophylaxis. J Shoulder Elbow Surg. 2015 Jun;24(6):844-7. doi: 10.1016/j.jse.2014.10.016. Epub 2014 Dec 26. |
| 26085528 | Background | Mook WR, Klement MR, Green CL, Hazen KC, Garrigues GE. The Incidence of Propionibacterium acnes in Open Shoulder Surgery: A Controlled Diagnostic Study. J Bone Joint Surg Am. 2015 Jun 17;97(12):957-63. doi: 10.2106/JBJS.N.00784. |
| 25483906 | Background | Sethi PM, Sabetta JR, Stuek SJ, Horine SV, Vadasdi KB, Greene RT, Cunningham JG, Miller SR. Presence of Propionibacterium acnes in primary shoulder arthroscopy: results of aspiration and tissue cultures. J Shoulder Elbow Surg. 2015 May;24(5):796-803. doi: 10.1016/j.jse.2014.09.042. Epub 2014 Dec 4. |
| 26067191 | Background | Sabetta JR, Rana VP, Vadasdi KB, Greene RT, Cunningham JG, Miller SR, Sethi PM. Efficacy of topical benzoyl peroxide on the reduction of Propionibacterium acnes during shoulder surgery. J Shoulder Elbow Surg. 2015 Jul;24(7):995-1004. doi: 10.1016/j.jse.2015.04.003. |