Effectiveness of a RF Sponge Detection
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ClinicalTrials.gov Identifier: NCT02837224 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Last Update Posted : November 30, 2017
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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 |
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Surgical Complication Nec | Device: The Situate Detection System |

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 |
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Preimplementation: Situate Locate System
Subjects/surgeries performed before implementation of the Situate Detection System.
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Implementation
Subjects/surgeries performed after implementation of the Situate Detection System.
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Device: The Situate Detection System
The Situate Detection System for locating surgical sponges
Other Name: RF Assure |
- 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
- 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
- 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
- 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
- Incorrect final counts [ Time Frame: 6 months after study start ]The frequency of incorrect final closing counts of surgical sponges.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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We estimate including 27,000 patients during the total of 18 months.
- 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.
- 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.

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
Principal Investigator: | Victoria J Steelman, PhD | University of Iowa |
Publications:
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 |
retained surgical sponge adverse event |
Foreign Bodies Wounds and Injuries |