Clinical Trial: Effectiveness of a RF Sponge Detection
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Effectiveness of a Radiofrequency Surgical Sponge Detection System for Preventing Retained Surgical Sponges
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.
Detailed Summary:
Background:
Retained surgical items (e.g. sponges, needles, and instruments) remain one of the sentinel events most frequently reported to The Joint Commission, and are estimated to occur in 1: 5500 surgeries. These serious adverse events have resulted in negative patient outcomes (reoperation, readmission/prolonged hospital stay, infection or sepsis, fistulas/ bowel obstructions, visceral perforation, and death). Cotton gauze sponges account for 48-69% of retained surgical items, and result in more serious tissue reaction than metal items. The national standard for prevention of retained surgical sponges relies heavily on manual counting, a process that occurs prior to incision, at the time of closing a cavity within a cavity, closing the first layer of tissue, and closing skin. The immediate outcome of the closing counts is either correct or unresolved. If unresolved, a series of steps are taken to reconcile the count (surgeon notified, wound searched, sterile field searched, room searched, count repeated). These steps require extra time and effort, pulling 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. The practice of searching for misplaced sponges and using radiography to rule out the presence of a retained sponge extend the operating time and add to costs associated care of the patient in surgery. Novel technology is now available for detecting and preventing retained surgical sponges. The technology uses a radiofrequency (RF) chip in the sponge, and a mat or wand that scans the patient for a sponge. Only one clinical trial has evaluated the in-use effectiveness of this RF technology. No retained sponges occurred during the 18 month trial. However the sample size was not large enough to determine significance.
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Iowa
Dates:
Date Received: July 7, 2016
Date Started: August 2016
Date Completion: August 2017
Last Updated: April 20, 2017
Last Verified: July 2016
