Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of a RF Sponge Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837224
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Victoria J Steelman, University of Iowa

Brief Summary:

Retained surgical items (e.g. sponges, needles, and instruments) remain the most frequently reported serious adverse event for five of the last six years. Retained surgical sponges have resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay, infection, fistulas/ bowel obstructions, and death). The national standard for prevention of retained surgical sponges relies heavily on manual counting several times before, during, and after the surgical procedure. If a sponge is missing, a series of steps are taken to reconcile the count. These steps require extra time and pull personnel away from other competing priorities. If the final closing count remains incorrect, it is common practice to obtain an intraoperative radiograph to rule out retention of a surgical sponge. This X-Ray is expensive and increases the time required for the surgery.

Novel technology using a radiofrequency (RF) is now available for detecting and preventing retained surgical sponges. The objective of this study is to evaluate the in-use effectiveness of a radiofrequency (RF) surgical sponge detection system for reducing the cost of searching for sponges and prevention of incorrect counts.


Condition or disease Intervention/treatment
Surgical Complication Nec Device: The Situate Detection System

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 27637 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Effectiveness of a Radiofrequency Surgical Sponge Detection System for Preventing Retained Surgical Sponges
Actual Study Start Date : August 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Group/Cohort Intervention/treatment
Preimplementation: Situate Locate System
Subjects/surgeries performed before implementation of the Situate Detection System.
Implementation
Subjects/surgeries performed after implementation of the Situate Detection System.
Device: The Situate Detection System
The Situate Detection System for locating surgical sponges
Other Name: RF Assure




Primary Outcome Measures :
  1. Time spent searching for sponges [ Time Frame: 6 months after study start ]
    The total annualized number of operating room minutes spent searching for missing surgical sponges

  2. Cost of time spent searching for sponges [ Time Frame: 6 months after study start ]
    The total annualized cost of operating room time spent searching for sponges

  3. Time spent using radiography to rule out the presence of a retained sponge [ Time Frame: 6 months after study start ]
    The total annualized number of operating room minutes spent ruling out the presence of a retained sponge using radiography

  4. Cost of using radiography to rule out the presence of a retained sponge [ Time Frame: 6 months after study start ]
    The total annualized cost of operating room time and radiography spent ruling out the presence of a retained sponge

  5. Incorrect final counts [ Time Frame: 6 months after study start ]
    The frequency of incorrect final closing counts of surgical sponges.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Surgical patients
Criteria

Inclusion Criteria:

  • We estimate including 27,000 patients during the total of 18 months.

    1. The first part of the sample will be retrospective, all patients undergoing surgery in the Main Operating Room during a 9 month period of time of the RF sponge detection system (February through October, 2014) This time frame was selected to allow inclusion of data from our previous study.
    2. The second part of the sample will be prospective, for nine months after implementation of the RF sponge detection system.

Exclusion Criteria:

  • ophthalmology, dentistry, non-surgical procedures, aborted surgical procedures, surgeries during which the patient expired, and surgeries performed outside of the Main Operating Room.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837224


Sponsors and Collaborators
University of Iowa
Investigators
Layout table for investigator information
Principal Investigator: Victoria J Steelman, PhD University of Iowa
Additional Information:
Publications:
Guideline for prevention of retained surgical items. In: AORN, ed. Guidelines for Perioperative Practice. 2014 ed. Denver, CO: Association of periOperative Registered Nurses; 2016.

Layout table for additonal information
Responsible Party: Victoria J Steelman, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02837224    
Other Study ID Numbers: 201602723
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Victoria J Steelman, University of Iowa:
retained surgical sponge
adverse event
Additional relevant MeSH terms:
Layout table for MeSH terms
Foreign Bodies
Wounds and Injuries