Status:
COMPLETED
The Bar Coded Sponge Study
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Patient Safety Technologies, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to test whether bar coded surgical sponges can significantly increase the safety of operations, specifically by (1) reducing discrepancies and miscounts, (2) reducing tota...
Detailed Description
Prior work by Dr. Gawande showed that the incidence of a retained foreign body is between 1 in 9000 and 1 in 19000 inpatient operations, or at least once a year for a hospital of any size. Leaving for...
Eligibility Criteria
Inclusion
- Patients undergoing a scheduled general surgery (or subspecialty of general surgery) procedure in the general surgery operating room of the Brigham and Women's Hospital in Boston, MA, during the study period are eligible for enrollment in the study.
- Start times for eligible cases must be between 7AM and 3PM on a weekday.
Exclusion
- Patients in the pre-op area who have already received pre-op sedation and have not yet been consented
- Patients who are undergoing a procedure by a specialty other than general surgery
- Patients whose procedure is being performed by a team whose members are not all trained to use the Bar Coded Sponge System
- After hours, weekend, add-on, or emergency cases
- Pregnant women
- Patients whose consent needs to be obtained through a surrogate
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00282750
Start Date
March 1 2006
End Date
August 1 2006
Last Update
January 14 2010
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115