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,
Craft RO, Damjanovic B, Colwell AS. Evidence-based protocol for infection control in immediate implant-based breast reconstruction. Ann Plast Surg. 2012 Oct;69(4):446-50. doi: 10.1097/SAP.0b013e31824a215a. — View Citation
Davis GB, Peric M, Chan LS, Wong AK, Sener SF. Identifying risk factors for surgical site infections in mastectomy patients using the National Surgical Quality Improvement Program database. Am J Surg. 2013 Feb;205(2):194-9. doi: 10.1016/j.amjsurg.2012.05.007. Epub 2012 Aug 31. — View Citation
Kalra L, Camacho F, Whitener CJ, Du P, Miller M, Zalonis C, Julian KG. Risk of methicillin-resistant Staphylococcus aureus surgical site infection in patients with nasal MRSA colonization. Am J Infect Control. 2013 Dec;41(12):1253-7. doi: 10.1016/j.ajic.2013.05.021. Epub 2013 Aug 21. — View Citation
Kirby JP, Mazuski JE. Prevention of surgical site infection. Surg Clin North Am. 2009 Apr;89(2):365-89, viii. doi: 10.1016/j.suc.2009.01.001. — View Citation
Salih L, Tevell S, Mansson E, Nilsdotter-Augustinsson A, Hellmark B, Soderquist B. Staphylococcus epidermidis isolates from nares and prosthetic joint infections are mupirocin susceptible. J Bone Jt Infect. 2018 Jan 1;3(1):1-4. doi: 10.7150/jbji.22459. eCollection 2018. — View Citation
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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