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ChloroPrep Wipes no longer available
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This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements.
Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.
Swabs will be taken over the operative knee by study personnel for a bacterial colony count immediately before surgical site preparation is started, after the surgery prep is complete, and 24 hours post surgery prep. Swabs will be sent to the lab for quantitative colony counts and all 3 measurements will be compared and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty. |
|
| Arm 2 | Active Comparator | Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swab area with Betadine | Drug | A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts. | Subjects scheduled to undergo primary total knee arthroplasty will be randomized to receive either a Betadine surgical scrub or ChloraPrep surgical scrub at the time of surgery. Subjects will be enrolled until swab #3 is obtained, 24 hours post-surgery. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Sporer, MD | Midwest Orthopaedics at Rush | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15866959 | Background | Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977. | |
| 15266508 | Background | Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2004;(3):CD003949. doi: 10.1002/14651858.CD003949.pub2. |
| Label | URL |
|---|---|
| Midwest Ortho at RUSH | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 16, 2015 | |
| Reset | Mar 2, 2015 | |
| Release | Mar 12, 2020 | |
| Reset | Mar 25, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 16, 2015 | Mar 2, 2015 | |||
| Mar 12, 2020 |
| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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|
| Swab area with ChloraPrep | Drug | A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery. |
|
|
| 3189943 | Background | Aly R, Maibach HI. Comparative antibacterial efficacy of a 2-minute surgical scrub with chlorhexidine gluconate, povidone-iodine, and chloroxylenol sponge-brushes. Am J Infect Control. 1988 Aug;16(4):173-7. doi: 10.1016/0196-6553(88)90029-6. |
| 7013126 | Background | Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. No abstract available. |
| 15379808 | Background | Grabsch EA, Mitchell DJ, Hooper J, Turnidge JD. In-use efficacy of a chlorhexidine in alcohol surgical rub: a comparative study. ANZ J Surg. 2004 Sep;74(9):769-72. doi: 10.1111/j.1445-1433.2004.03154.x. |
| 16490971 | Background | Nishimura C. Comparison of the antimicrobial efficacy of povidone-iodine, povidone-iodine-ethanol and chlorhexidine gluconate-ethanol surgical scrubs. Dermatology. 2006;212 Suppl 1:21-5. doi: 10.1159/000089195. |
| 6612574 | Background | Geelhoed GW, Sharpe K, Simon GL. A comparative study of surgical skin preparation methods. Surg Gynecol Obstet. 1983 Sep;157(3):265-8. |
| 15866960 | Background | Keblish DJ, Zurakowski D, Wilson MG, Chiodo CP. Preoperative skin preparation of the foot and ankle: bristles and alcohol are better. J Bone Joint Surg Am. 2005 May;87(5):986-92. doi: 10.2106/JBJS.D.02695. |
| Mar 25, 2020 |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |