Reducing Perioperative S. Aureus Transmission
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|ClinicalTrials.gov Identifier: NCT03638947|
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcus Aureus Health Care Associated Infection Health Care Worker Patient Transmission||Device: Swab and decolonization using povidone-iodine cleansing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2800 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||After the patient has signed consent, they will receive a pre-surgical kit that will include swabs to be used in the nares, arm pit and groin area (standard of care). In a 1:1 randomization scheme, one half of the patients will receive povidone-iodine swab in addition to the kit (treatment).|
|Primary Purpose:||Health Services Research|
|Official Title:||Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)|
|Actual Study Start Date :||September 20, 2018|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
No Intervention: Standard of Care
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
Active Comparator: Swab kit plus povidone-iodine soap
Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery.
Device: Swab and decolonization using povidone-iodine cleansing
Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
- Identify the number of perioperative S. aureus reservoirs using collection kits [ Time Frame: Perioperative time. ]To identify locations that harbor S. aureus reservoirs immediately prior to surgery and during the operative procedure, the investigators will surveil the patient's skin, surgical team's hands, injection ports of the patient's catheters and environmental sites within the operating room suite using sterile collection kits.
- Map the number of S. aureus transmission events using OR Path Trac software [ Time Frame: Up to 180 days following surgery ]OR Path Trac software algorithms will map how S. aureus is transmitted from an initially identified reservoir to another location within the perioperative arena.
- Quantitate the reduction of S. aureus tranmission [ Time Frame: Up to 180 days following surgery ]Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638947
|Contact: Randy Loftus, MDemail@example.com|
|Contact: Zita A Sibenaller, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Randy Loftus, MD|
|Principal Investigator:||Randy Loftus, MD||University of Iowa|