Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02252562
Other study ID # D13081
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date August 2015

Study information

Verified date February 2019
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public health concerns that impact all areas of healthcare. Further work is needed to better understand these healthcare issues so that effective preventive measures can be developed.

The investigators have developed and validated an experimental model for studying the risk factors for bacterial cross contamination in the surgical operating room. The investigators have confirmed in our previous work that intraoperative bacterial transmission events occur frequently both within and between surgical cases and that these transmission events are linked to 30-day postoperative HCAIs and increased patient mortality.

In response, the investigators have implemented various strategies designed to bacterial transmission in the operating room, including anesthesia provider hand hygiene compliance. The investigators' recent work in the intensive care unit suggests that the hand hygiene system the investigators have previously studied could be further optimized.

The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene system enhanced with novel wireless technology designed to facilitate real-time group and individual performance feedback.

The investigators hypothesize that the use of this system will increase hourly hand decontamination events of anesthesia and circulating nurse providers and reduce 30-day postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay duration, and hospital re-admission rates, and mortality(secondary outcomes).


Description:

Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public health concerns that impact all healthcare arenas. Further work is indicated to better understand these healthcare issues in order that effective preventive measures can be developed.

The investigators have developed and validated an experimental model for studying the mechanisms, risk factors for, and implications of bacterial cross contamination in the surgical operating room. The investigators have confirmed through use of this model that intraoperative bacterial transmission events occur frequently within and between operative cases and that these transmission events are linked to 30-day postoperative HCAIs and to increased patient mortality. In response, the investigators have implemented and evaluated various strategies designed to target risk factors for intraoperative bacterial transmission events including anesthesia provider hand hygiene compliance, improved handling and design of intravascular catheters, and improved environmental decontamination of high-risk objects. While these focused strategies have been successful in reducing transmission events and the incidence of 30-day postoperative infections, the investigators' recent work in the intensive care unit suggests that the hand hygiene system the investigators studied could be further optimized. The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene system enhanced with novel wireless technology designed to facilitate real-time group and individual performance feedback, two evidence-based educational interventions, in reducing 30-day postoperative HCAIs (primary outcome) and intraoperative bacterial transmission events, hospital stay duration, and hospital re-admission rates (secondary outcomes).


Recruitment information / eligibility

Status Completed
Enrollment 3256
Est. completion date August 2015
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Operating room environments involving adult patients undergoing general anesthesia, according to usual practice, for elective or urgent and emergent orthopedic, plastic, neurosurgical, cardiothoracic, urological, general abdominal, gynecological, vascular, or ear/nose/and throat surgical procedures

2. Requirement of a peripheral and/or central intravenous catheter

Surgical inclusion procedures were selected because they captured the majority of 30-day postoperative infections in a prior multi-center study that we conducted across three major academic medical centers [3].

The investigators will [randomize by the day in order to ensure that the treatment and control arms maintain their integrity and to facilitate an environment conducive to behavior change.] The investigators anticipate that the randomization strategy will allow equal distribution of urgent and emergent patients in the treatment and control groups. Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions (see below). The investigators realize that decolonization procedures have the capacity to reduce the effect size, and as such, we have appropriately adjusted the sample size (see statistical section).

Exclusion Criteria:

1. Pediatric patients

2. Lack of an intravenous catheter

3. Pregnant

4. A surgical procedure outside of the classes listed above

5. Adjustments on the day of surgery given the following considerations:

- Provider allergy/intolerance to 64% alcohol: In the case where the primary anesthesia provider conveys a prior allergy to 64% alcohol and/or a history of significant contact dermatitis, the operating room will be excluded from enrollment. If a primary anesthesia provider develops an allergy and/or contact dermatitis during the study period, this will be documented, and operating rooms assigned to the primary anesthesia provider for future cases will be excluded. The expectation will be that all key providers working in operating rooms randomized to the intervention will participate in utilization of the device. If an operating room is randomized and a provider subsequently refuses to participate for any reason, the operating room will be excluded from the primary analysis but included in an intention-to-treat analysis. An additional operating room will be randomized for each such occurrence.

Study Design


Related Conditions & MeSH terms

  • Complication of Surgical Procedure
  • Infection

Intervention

Device:
Sage Personal Hand Hygiene System
Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.

Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Sage Products, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 Healthc — View Citation

Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Hand Hygiene Events Per Hour Utilizing the Device The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group. During active OR cases
Primary Number of Participants With Postoperative Healthcare Acquired Infections Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions. 30-day after surgery
Secondary Hospital Re-admission Rates Readmission to the hospital within 30 days of discharge Within 30 days of discharge
Secondary Mortality Patient Mortality Within 30 Days of discharge
Secondary Hospital Duration Duration of Hospital Stay 30 days after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT02789579 - The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy Early Phase 1
Withdrawn NCT02374294 - TCOT Effectiveness in Preventing Wound Infections in Perineal Resections Phase 2
Completed NCT01757704 - Factors Responsible for the Effectiveness of the Lund De-airing Technique N/A
Recruiting NCT05005117 - Laparoscopic Approach for Emergency Colon Resection N/A
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Completed NCT04849702 - Comparison of the Clavien-Dindo and Comprehensive Complication Index
Completed NCT04120324 - Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
Not yet recruiting NCT06199401 - Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery N/A
Recruiting NCT05761821 - Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
Active, not recruiting NCT05795127 - Risk for Reoperation After First MTP Joint Arthrodesis
Completed NCT04550156 - Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections N/A
Recruiting NCT05194943 - Trends and Safety in Revisional Bariatric Surgery in Italy
Not yet recruiting NCT03313986 - Outcomes of Surgical Correction of Penile Curvature in Adult N/A
Enrolling by invitation NCT04456530 - Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study Phase 2/Phase 3
Completed NCT03125798 - Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy N/A
Completed NCT04226482 - Review of Efficacy of Used ultraSonic Energy Device N/A
Completed NCT01739374 - Efficacy and Safety of Reduced Pelvic Floor Mesh Implants Phase 2/Phase 3
Completed NCT01346709 - Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe
Enrolling by invitation NCT06394908 - Registry of MIUS for Urolithiasis (ReMIUS-U)
Recruiting NCT02212054 - A Trial on Treatments of Hirschsprung Allied Disease N/A