Effectiveness of a RF Sponge Detection
|ClinicalTrials.gov Identifier: NCT02837224|
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : November 30, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||27637 participants|
|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|
Preimplementation: Situate Locate System
Subjects/surgeries performed before implementation of the Situate Detection System.
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837224
|Principal Investigator:||Victoria J Steelman, PhD||University of Iowa|