NCT01426217

Brief Summary

The purpose of this study is to investigate whether implementing a novel syringe and IV stopcock cap system impregnated with alcohol will reduce IV catheter bacterial contamination and infections in patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
594

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
7 years until next milestone

Results Posted

Study results publicly available

October 18, 2018

Completed
Last Updated

October 18, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

August 29, 2011

Results QC Date

August 20, 2018

Last Update Submit

September 20, 2018

Conditions

Post-operative Infections

Keywords

IV contaminationintravenous contaminationstopcock contaminationsurgical site infection

Outcome Measures

Primary Outcomes (1)

  • Presence of Bacterial IV Stopcock Lumen Contamination

    The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed

    48 hours

Secondary Outcomes (1)

  • Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination

    Until positive, up to 5 days

Study Arms (2)

Control

NO INTERVENTION

Control arm using standard of care operating room procedures and equipment

Problem Solving Innovations (PSI) Experimental

EXPERIMENTAL

Implementation of the passive bundle including HubScrub and DocIt

Device: Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt

Interventions

Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocItDEVICE

Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.

Also known as: PSI Medical HubScrub, PSI Medical DocIt
Problem Solving Innovations (PSI) Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient undergoing surgery or procedure in operating room
  • Undergoing general anesthesia

You may not qualify if:

  • Children (age \< 18 years)
  • Lack of intravenous access
  • failure of anesthesia provider to complete training on experimental device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (4)

  • 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.

    PMID: 20686007BACKGROUND

  • 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.

    PMID: 19352154BACKGROUND

  • 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.

    PMID: 18719437BACKGROUND

  • Loftus RW, Brindeiro BS, Kispert DP, Patel HM, Koff MD, Jensen JT, Dodds TM, Yeager MP, Ruoff KL, Gallagher JD, Beach ML, Brown JR. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a passive catheter care system. Anesth Analg. 2012 Dec;115(6):1315-23. doi: 10.1213/ANE.0b013e31826d2aa4. Epub 2012 Nov 9.

    PMID: 23144441RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Randy Loftus, MD
Organization
Dartmouth-Hitchcock Medical Center
Randy.W.Loftus@hitchcock.org
(603) 650-6177

Study Officials

  • Bryan S Brindeiro, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

  • Randy W Loftus, MD

    Dartmouth-Hitchcock Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2011

First Posted

August 31, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

October 18, 2018

Results First Posted

October 18, 2018

Record last verified: 2018-08

Locations

US(1)