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Effectiveness of a RF Sponge Detection

NCT02837224 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27637

Last updated 2017-11-30

No results posted yet for this study

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.

Conditions

  • Surgical Complication Nec

Interventions

DEVICE

The Situate Detection System

The Situate Detection System for locating surgical sponges

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Victoria J Steelman, PhD · University of Iowa

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02837224 on ClinicalTrials.gov