Health Care Associated Infection, Health Care Worker Patient Transmission, Staphylococcus Aureus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESwab and decolonization using povidone-iodine cleansing
Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
Sponsors
RDB Bioinformatics
Randy Loftus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years of age * Undergoing surgery (orthopedic total joint, orthopedic spine, Gynecological/Oncology, thoracic, general, hernia, colorectal, open vascular, plastic surgery and open urological) * Ability to sign informed consent * Require general or regional anesthesia
Exclusion criteria
* Less than 18 years of age * Inability to sign informed consent * Procedures not included above * Not requiring general or regional anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitate the Reduction of S. Aureus Tranmission | Up to 180 days following surgery | Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits | Preoperative | To identify the number of patients in the preoperative setting who test positive for S. aureus. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Patient will receive by mail a kit containing swab for the nares, armpit and groin. | 130 |
| 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. | 106 |
| Total | 236 |
Baseline characteristics
| Characteristic | Swab Kit Plus Povidone-iodine Soap | Total | Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 87 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 148 Participants | 88 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 106 participants | 236 participants | 130 participants |
| Sex: Female, Male Female | 43 Participants | 155 Participants | 112 Participants |
| Sex: Female, Male Male | 63 Participants | 81 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 106 |
| other Total, other adverse events | 0 / 130 | 0 / 106 |
| serious Total, serious adverse events | 0 / 130 | 0 / 106 |
Outcome results
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.
Time frame: Up to 180 days following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Quantitate the Reduction of S. Aureus Tranmission | 1.25 events | Standard Deviation 2.11 |
| Swab Kit Plus Povidone-iodine Soap | Quantitate the Reduction of S. Aureus Tranmission | 0.47 events | Standard Deviation 1.13 |
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.
Time frame: Preoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits | 18 number of participants |
| Swab Kit Plus Povidone-iodine Soap | Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits | 8 number of participants |