Surgical Wound Infection Clinical Trial
Official title:
A Prospective Single-blind Placebo-controlled Trial to Establish the Efficacy and Tolerability of 10% Povidone-Iodine for Nasal S. Aureus and Methicillin Resistant S. Aureus (MRSA) Decolonization Among Patients Undergoing Same-day Surgery
Verified date | February 2024 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal carriage of Staphylococcus aureus and MRSA. To determine whether a more convenient, single-dose, pre-operative 10% povidone-iodine (PI) application is effective in reducing nasal carriage of S. aureus and MRSA. We expect a statistically significant decrease in S. aureus/MRSA colonization in nasal cultures taken perioperatively after intervention in patients who received pretreatment with PI as compared to patients who received normal saline (NS).
Status | Completed |
Enrollment | 192 |
Est. completion date | November 17, 2023 |
Est. primary completion date | November 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - community-based patients ages 18-80 - American Society of Anesthesiology (ASA) 1-3 - undergoing an outpatient surgery for at least 1 hour and up to 6 hours duration Exclusion Criteria: - pregnancy - allergy to povidone-iodine - infectious indication for surgery or preexisting known infection/wound - immunocompromised state - use of chemotherapy or steroids within 30 days prior to surgery - use of antimicrobial therapy within 30 days prior to surgery - surgeries where field avoidance prevents intraoperative access to the nares |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total CFU (colony forming units) | Enumeration of nasal swab samples | Perioperative Course 5 hour maximum | |
Secondary | Wound infection | Presence of wound infection | Up to 30 days |
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