Complication of Surgical Procedure Clinical Trial
Official title:
Reduction in 30-Day Postoperative Healthcare-Associated Infections Through Use of a Novel Hand Hygiene System
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 |
Verified date | February 2019 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Sage Products, Inc. |
United States,
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
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 |
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 |