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Reducing Perioperative S. Aureus Transmission

Sponsor
Randy Loftus (Other)
Overall Status
Terminated
CT.gov ID
NCT03638947
Collaborator
RDB Bioinformatics, LLC (Other)
236
Enrollment
1
Location
2
Arms
27.4
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Swab and decolonization using povidone-iodine cleansing
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
236 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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).
Primary Purpose:
Health Services Research
Official Title:
Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)
Actual Study Start Date :
Sep 20, 2018
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care

Patient will receive by mail a kit containing swab for the nares, armpit and groin.
Active Comparator: 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.

Device: Swab and decolonization using povidone-iodine cleansing
Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242

Sponsors and Collaborators

  • Randy Loftus
  • RDB Bioinformatics, LLC

Investigators

  • Principal Investigator: Randy Loftus, MD, University of Iowa

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Randy Loftus, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT03638947
Other Study ID Numbers:
  • 201802843
First Posted:
Aug 20, 2018
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Cross Infection
Povidone-Iodine
Povidone

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Standard of Care Swab Kit Plus Povidone-iodine Soap
Arm/Group Description Patient will receive by mail a kit containing swab for the nares, armpit and groin. 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.
Period Title: Overall Study
STARTED 130 106
COMPLETED 130 106
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Standard of Care Swab Kit Plus Povidone-iodine Soap Total
Arm/Group Description Patient will receive by mail a kit containing swab for the nares, armpit and groin. 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. Total of all reporting groups
Overall Participants 130 106 236
Age (Count of Participants)
<=18 years
0
0%
1
0.9%
1
0.4%
Between 18 and 65 years
88
67.7%
60
56.6%
148
62.7%
>=65 years
42
32.3%
45
42.5%
87
36.9%
Sex: Female, Male (Count of Participants)
Female
112
86.2%
43
40.6%
155
65.7%
Male
18
13.8%
63
59.4%
81
34.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United States
130
100%
106
100%
236
100%

Outcome Measures

1. Primary Outcome
Title Quantitate the Reduction of S. Aureus Tranmission
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Swab Kit Plus Povidone-iodine Soap
Arm/Group Description Patient will receive by mail a kit containing swab for the nares, armpit and groin. 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.
Measure Participants 130 106
Mean (Standard Deviation) [events]
1.25
(2.11)
0.47
(1.13)
2. Secondary Outcome
Title Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits
Description To identify the number of patients in the preoperative setting who test positive for S. aureus.
Time Frame Preoperative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care Swab Kit Plus Povidone-iodine Soap
Arm/Group Description Patient will receive by mail a kit containing swab for the nares, armpit and groin. 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.
Measure Participants 130 106
Number [number of participants]
18
13.8%
8
7.5%

Adverse Events

Time Frame 1 year
Adverse Event Reporting Description
Arm/Group Title Standard of Care Swab Kit Plus Povidone-iodine Soap
Arm/Group Description Patient will receive by mail a kit containing swab for the nares, armpit and groin. 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.
All Cause Mortality
Standard of Care Swab Kit Plus Povidone-iodine Soap
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/130 (0%) 0/106 (0%)
Serious Adverse Events
Standard of Care Swab Kit Plus Povidone-iodine Soap
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/130 (0%) 0/106 (0%)
Other (Not Including Serious) Adverse Events
Standard of Care Swab Kit Plus Povidone-iodine Soap
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/130 (0%) 0/106 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Randy W. Loftus
Organization UIOWA
Phone 6033066475
Email randy-loftus@uiowa.edu
Responsible Party:
Randy Loftus, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT03638947
Other Study ID Numbers:
  • 201802843
First Posted:
Aug 20, 2018
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022