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Intermediate analysis produced strong enough results that full study not needed.
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| Name | Class |
|---|---|
| RDB Bioinformatics | INDUSTRY |
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The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery.
The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery. The investigators will combine several approaches in a "bundle" of activities to achieve this goal. The bundle will include removal of bacterial pathogens from patient skin sites before surgery, from provider hands before, during, and after surgery, from environmental surfaces before and after terminal cleaning, and from the injection ports of patient intravenous catheters. The investigators will use a new surveillance system to evaluate how well the bundle, and each component of the bundle, is working. Surveillance will identify S. aureus transmission events, and movement of S. aureus between reservoirs before, during, and after surgery (perioperative). Surveillance will map transmission events to identify actionable steps to improve the bundle. An infection control perioperative team will act on the surveillance reports to proactively address the action items, and to measure the effect of their efforts for the treatment group. The investigators will compare perioperative S. aureus transmission events for patients receiving the bundle to perioperative S. aureus transmission events for patients receiving usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Patient will receive by mail a kit containing swab for the nares, armpit and groin. | |
| Swab kit plus povidone-iodine soap | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swab and decolonization using povidone-iodine cleansing | Device | Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitate the Reduction of S. Aureus Tranmission | Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions. | Up to 180 days following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits | To identify the number of patients in the preoperative setting who test positive for S. aureus. | Preoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randy Loftus, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23082877 | Background | Vogel TR, Dombrovskiy VY, Lowry SF. Impact of infectious complications after elective surgery on hospital readmission and late deaths in the U.S. Medicare population. Surg Infect (Larchmt). 2012 Oct;13(5):307-11. doi: 10.1089/sur.2012.116. Epub 2012 Oct 19. | |
| 27267310 | Background | Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7. |
| Label | URL |
|---|---|
| Fact Sheet: Obama Administration Takes Actions to Combat Antibiotic-Resistant Bacteria | View source |
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All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Patient will receive by mail a kit containing swab for the nares, armpit and groin. |
| FG001 | 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. Swab and decolonization using povidone-iodine cleansing: Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Patient will receive by mail a kit containing swab for the nares, armpit and groin. |
| BG001 | 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. Swab and decolonization using povidone-iodine cleansing: Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing. |
| 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 | Quantitate the Reduction of S. Aureus Tranmission | Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions. | Posted | Mean | Standard Deviation | events | Up to 180 days following surgery |
|
1 year
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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 | Standard of Care | Patient will receive by mail a kit containing swab for the nares, armpit and groin. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy W. Loftus | UIOWA | 6033066475 | randy-loftus@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2018 | Jun 7, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2018 | Jun 7, 2022 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2019 | May 17, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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).
| 10580621 | Background | Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572. |
| 19035777 | Background | Boucher HW, Talbot GH, Bradley JS, Edwards JE, Gilbert D, Rice LB, Scheld M, Spellberg B, Bartlett J. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jan 1;48(1):1-12. doi: 10.1086/595011. |
| 18719437 | Background | Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855. |
| 22467892 | Background | Loftus RW, Brown JR, Koff MD, Reddy S, Heard SO, Patel HM, Fernandez PG, Beach ML, Corwin HL, Jensen JT, Kispert D, Huysman B, Dodds TM, Ruoff KL, Yeager MP. Multiple reservoirs contribute to intraoperative bacterial transmission. Anesth Analg. 2012 Jun;114(6):1236-48. doi: 10.1213/ANE.0b013e31824970a2. Epub 2012 Mar 30. |
| 25444268 | Background | Clark C, Taenzer A, Charette K, Whitty M. Decreasing contamination of the anesthesia environment. Am J Infect Control. 2014 Nov;42(11):1223-5. doi: 10.1016/j.ajic.2014.07.016. Epub 2014 Oct 30. |
| 29907449 | Background | Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12. |
| 29307750 | Background | Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4. |
| 29395508 | Background | Hadder B, Patel HM, Loftus RW. Dynamics of intraoperative Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter transmission. Am J Infect Control. 2018 May;46(5):526-532. doi: 10.1016/j.ajic.2017.10.018. Epub 2018 Feb 12. |
| 20686007 | Background | Loftus RW, Muffly MK, Brown JR, Beach ML, Koff MD, Corwin HL, Surgenor SD, Kirkland KB, Yeager MP. Hand contamination of anesthesia providers is an important risk factor for intraoperative bacterial transmission. Anesth Analg. 2011 Jan;112(1):98-105. doi: 10.1213/ANE.0b013e3181e7ce18. Epub 2010 Aug 4. |
| 32219407 | Derived | Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934. |
| Updated Guidelines for Evaluating Public Health Surveillance Systems | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits | To identify the number of patients in the preoperative setting who test positive for S. aureus. | Posted | Number | number of participants | Preoperative |
|
|
|
| 0 |
| 130 |
| 0 |
| 130 |
| 0 |
| 130 |
| EG001 | 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. Swab and decolonization using povidone-iodine cleansing: Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing. | 0 | 106 | 0 | 106 | 0 | 106 |
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| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |