NCT02837224

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27,637

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

July 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

November 30, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

July 7, 2016

Last Update Submit

November 28, 2017

Conditions

Surgical Complication Nec

Keywords

retained surgical spongeadverse event

Outcome Measures

Primary Outcomes (5)

  • Time spent searching for sponges

    The total annualized number of operating room minutes spent searching for missing surgical sponges

    6 months after study start

  • Cost of time spent searching for sponges

    The total annualized cost of operating room time spent searching for sponges

    6 months after study start

  • Time spent using radiography to rule out the presence of a retained sponge

    The total annualized number of operating room minutes spent ruling out the presence of a retained sponge using radiography

    6 months after study start

  • Cost of using radiography to rule out the presence of a retained sponge

    The total annualized cost of operating room time and radiography spent ruling out the presence of a retained sponge

    6 months after study start

  • Incorrect final counts

    The frequency of incorrect final closing counts of surgical sponges.

    6 months after study start

Study Arms (2)

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

Interventions

The Situate Detection SystemDEVICE

The Situate Detection System for locating surgical sponges

Also known as: RF Assure
Implementation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients

You may qualify if:

  • We estimate including 27,000 patients during the total of 18 months.
  • The second part of the sample will be prospective, for nine months after implementation of the RF sponge detection system.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008 Jul;207(1):80-7. doi: 10.1016/j.jamcollsurg.2007.12.047. Epub 2008 May 23.

    PMID: 18589366BACKGROUND

  • Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003 Jan 16;348(3):229-35. doi: 10.1056/NEJMsa021721.

    PMID: 12529464BACKGROUND

  • Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, Heniford BT. Retained foreign bodies after surgery. J Surg Res. 2007 Apr;138(2):170-4. doi: 10.1016/j.jss.2006.08.001. Epub 2007 Feb 1.

    PMID: 17275034BACKGROUND

  • Guideline for prevention of retained surgical items. In: AORN, ed. Guidelines for Perioperative Practice. 2014 ed. Denver, CO: Association of periOperative Registered Nurses; 2016.

    BACKGROUND

  • Williams TL, Tung DK, Steelman VM, Chang PK, Szekendi MK. Retained surgical sponges: findings from incident reports and a cost-benefit analysis of radiofrequency technology. J Am Coll Surg. 2014 Sep;219(3):354-64. doi: 10.1016/j.jamcollsurg.2014.03.052. Epub 2014 May 10.

    PMID: 25081938BACKGROUND

  • Steelman VM, Schaapveld AG, Perkhounkova Y, Storm HE, Mathias M. The Hidden Costs of Reconciling Surgical Sponge Counts. AORN J. 2015 Nov;102(5):498-506. doi: 10.1016/j.aorn.2015.09.002.

    PMID: 26514707BACKGROUND

  • Rupp CC, Kagarise MJ, Nelson SM, Deal AM, Phillips S, Chadwick J, Petty T, Meyer AA, Kim HJ. Effectiveness of a radiofrequency detection system as an adjunct to manual counting protocols for tracking surgical sponges: a prospective trial of 2,285 patients. J Am Coll Surg. 2012 Oct;215(4):524-33. doi: 10.1016/j.jamcollsurg.2012.06.014. Epub 2012 Jul 6.

    PMID: 22770865BACKGROUND

  • Hart S, Hashemi L, Sobolewski CJ. Effect of a disposable automated suturing device on cost and operating room time in benign total laparoscopic hysterectomy procedures. JSLS. 2013 Oct-Dec;17(4):508-16. doi: 10.4293/108680813X13693422522231.

    PMID: 24398190BACKGROUND

  • Dossett LA, Dittus RS, Speroff T, May AK, Cotton BA. Cost-effectiveness of routine radiographs after emergent open cavity operations. Surgery. 2008 Aug;144(2):317-21. doi: 10.1016/j.surg.2008.03.012. Epub 2008 Jun 5.

    PMID: 18656641BACKGROUND

MeSH Terms

Conditions

Foreign Bodies

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Victoria J Steelman, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 19, 2016

Study Start

August 1, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

November 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share