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Clinical trial

Feasibility of Pre-operative Povidone Iodine Decolonization Among Orthopedic Trauma Surgery Patients To Reduce Staphylococcus Aureus Surgical Site Infections

ID
Name
201812801
Description
Many surgical site infections are caused by bacteria that is transferred from a patient's nose to their open surgical wound. Some small studies have shown that putting povidone-iodine in a patient's nose reduces this risk. This study aims to evaluate the real-world effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University of Iowa.
Trial arms
Trial start
2020-02-19
Estimated PCD
2021-06-08
Trial end
2021-06-08
Status
Completed
Phase
Early phase I
Treatment
intranasal povidone-iodine
povidone-iodine USP, 10% w/w antiseptic
Arms:
Nasal povidone-iodine
Other names:
PROFEND
Size
65
Primary endpoint
Number of Participants With Staphylococcus Aureus Nasal Colonization
Within 6 hours after first dose of povidone-iodine
Eligibility criteria
Inclusion Criteria: * Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period. Exclusion Criteria: * Patients unable to provide informed consent due to head trauma or dementia.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '50 patients will receive PROFEND intranasal povidone-iodine prior to surgery and after surgery. The study aims to evaluate the real-world effectiveness of PROFEND® in reducing S. aureus colonization and surgical site infections (SSIs).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}
Updated at
2023-06-28

1 organization

1 product

1 indication

Organization
University of Iowa
Product
Povidone-Iodine
Indication
SSIs