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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).
This will be a prospective single-blinded randomized placebo-controlled trial of two applications of a nasal 10% Povidone Iodine (PI) solution used on the intranasal mucosal surfaces of each nostril in the preoperative holding area within 2 h prior to surgical incision compared with NS using the same technique. Both the PI and NS will be applied by rotating the swab over the intranasal mucosal surface for 15 seconds; this process will be performed twice for both nostrils, using a new swab for each application. Nasal cultures will be obtained prior to PI or NS application as well as intraoperatively 1 hour and 2 hours after first surgical incision. The primary study end point is the decrease in S. aureus/MRSA colony forming units (CFU) in nasal cultures taken within 2 hours after intervention in patients who presented with a positive preintervention nasal culture. A secondary endpoint is the presence or absence of surgical site infections within 30 days postoperatively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Application of Povidone-Iodine 10% prior to surgery to Nares |
|
| placebo | Placebo Comparator | Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine 10% | Drug | Nasal swab stick application of Povidone-Iodine 10% prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU. | 1, 2, and 3 hours after application of Povidone-Iodine or saline solution |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infections | The presence of surgical site infections | at 7 and 30-day postoperative intervals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Bekker, MD/PhD | Rutgers University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19281889 | Background | 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. | |
| 22944390 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Application of Povidone-Iodine 10% prior to surgery to Nares Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery |
| FG001 | Placebo | Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares 0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Nasal samples were analyzed for 88 participants randomized to the treatment group and 91 participants randomized to the placebo group.
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Application of Povidone-Iodine 10% prior to surgery to Nares Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU. | Nasal samples (NS) taken from 42 participants out of 95 assigned to the treatment group, and 47 out of 97 assigned to the placebo group that tested positive for S. aureus before the intervention were analyzed at every following time point: 1, 2, and 3 hours after the intervention (AI). NS taken from 32 participants out of 95 assigned to the treatment group, and 35 out of 97 assigned to the placebo group were positive for MRSA at baseline and were analyzed for MRSA at 1,2, and 3 hours AI. | Posted | Median | Inter-Quartile Range | CFU per sample (∆) | 1, 2, and 3 hours after application of Povidone-Iodine or saline solution | nasal samples | nasal samples |
From the time the patient signs the Informed Consent Form for 24 hours or until discharge from the hospital, whatever comes first, an average of 12 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Application of Povidone-Iodine 10% prior to surgery to Nares Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasal irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | itching |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dennis Grech | Rutgers - NJ Medical School | 973 972-5007 | grechde@njms.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2023 | Oct 7, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2023 | Feb 3, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Patients are assigned to treatment group or placebo
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| 0.9% NaCl Solution | Drug | Nasal swab stick application of 0.9% NaCl Solution prior to surgery |
|
|
| 22964685 | Background | 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. |
| 23973424 | Background | 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. |
| 29291157 | Background | 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. |
Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery
| BG002 | Total | Total of all reporting groups |
| Nasal samples |
|
| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
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| Number of S. aureus/ MRSA colony-forming unit (CFU) per Sample | Row population differs from the overall as nasal samples of 7 participants from the treatment group and 6 from the placebo group were not analyzed due to shipment delay or other reasons. | Median | Inter-Quartile Range | CFU per sample | Participants |
|
|
| ID | Title | Description |
|---|---|---|
| OG000 | Treatment | Application of Povidone-Iodine 10% prior to surgery to Nares Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery |
| OG001 | Placebo | Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares 0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery |
|
|
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| Secondary | Surgical Site Infections | The presence of surgical site infections | Row population differs from the overall as the secondary outcome was analyzed for 88 out of 95 participants assigned to the treatment group and 91 out of 97 to the placebo group. | Posted | Count of Participants | Participants | at 7 and 30-day postoperative intervals |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| 2 |
| 95 |
| EG001 | Placebo | Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares 0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery | 0 | 97 | 0 | 97 | 0 | 97 |
|
| nasal irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | running nose |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Prefer not to identify |
|
| Unknown |
|
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| Asian |
|
| Hispanic or Latino |
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| Other |
|
| Unknown |
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| Number of MRSA CFU per Sample |
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