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The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no reapplication | No Intervention | This group will not have chloraprep reapplied after their surgery and prior to dressing application. | |
| reapplication | Experimental | This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloraprep | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| quantitative bacterial colonization | Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms | 14-21 days |
| positive culture rate | Compare the overall positive culture rate between the two treatment groups | 14-21 days |
| Measure | Description | Time Frame |
|---|---|---|
| bacterial strain identification | Assess the total number of bacterial strains and identifying those strains cultured from swabs taken immediately adjacent to the wound during dressing change | 14-21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy P Morgan, MS | Contact | 605-328-1398 | jeremy.morgan@sanfordhealth.org | |
| Diane Hahn | Contact | 605-328-1361 | diane.hahn@sanfordhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Kyle T Judd, MD | Sanford Orthopedics and Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford USD Medical Center | Recruiting | Sioux Falls | South Dakota | 57117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22913092 | Background | Gould D. Causes, prevention and management of surgical site infection. Nurs Stand. 2012 Jul 25-31;26(47):47-56; quiz 58. doi: 10.7748/ns2012.07.26.47.47.c9226. | |
| 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 28, 2017 | |
| Reset | Jul 26, 2017 | |
| Release | Aug 16, 2017 | |
| Reset | Sep 14, 2017 | |
| Release | Oct 6, 2017 | |
| Reset | Oct 10, 2017 | |
| Release | Mar 19, 2018 | |
| Reset | Apr 16, 2018 | |
| Release | Jan 18, 2024 | |
| Reset | Feb 13, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 28, 2017 | Jul 26, 2017 | |||
| Aug 16, 2017 |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 20054046 | Background | Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988. |
| 15912075 | Background | Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008. |
| 12131506 | Background | Hibbard JS, Mulberry GK, Brady AR. A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs. 2002 Jul-Aug;25(4):244-9. doi: 10.1097/00129804-200207000-00007. |
| Sep 14, 2017 |
| Oct 6, 2017 | Oct 10, 2017 |
| Mar 19, 2018 | Apr 16, 2018 |
| Jan 18, 2024 | Feb 13, 2024 |