Tuesday, June 25, 2013: 3:50 PM
Richard I. Murahata, Ph.D., Hollister Incorporated, Principal Clinical Research Scientist, Libertyville, IL, Michael Riemer, M.S., Hollister Incorporated, Senior Statistician, Libertyville, IL and Eberhardt Gläser, MD, Independent Medical Consultant, Medical Consultant, Herdecke, Germany
Contamination of wounds and dressings with fecal material can lead to an increased risk of nosocomial infections. This was a balanced, randomized controlled study to determine the effect of using a bowel management system during the pre-operative bowel cleansing phase and for the 14 day period following surgery for decubitus ulcer revision. Patients in the Control Arm received the institution’s standard of care. The study was approved by the Ethikkommission, Ernst-Moritz-Arndt Universität Greifswald and was conducted at the Neurologisches Rehabilitationszentrum in Greifswald, Germany. All patients provided written informed consent prior to being screened and enrolled in the study. The primary measure was patient care costs including overall nursing time and supplies, length of stay, loss of operating room time due to soiling during pre-operative phase and cost of treating secondary infection. Secondary objectives included incidence of secondary infection during recovery, number of delayed surgeries due to pre-operative soiling and number of diversionary ostomies that were avoided.
The study completed with a total of 30 patients, 16 in the Test Arm and 14 in the Control Arm. There were no reported adverse events and no withdrawals. There was a significant difference in favor of the Test Group with respect to nursing time, cost of supplies, physician time and length of stay.
No significant difference regarding loss of operating room time was noted. None of the patients in the Test Arm ended the study with an infection, while three patients in the Control Arm had infections by the end of the study. This difference in proportions of secondary infections is not statistically significant.
The results of this study showed that use of a bowel management system provided a significant economic benefit. A similar benefit may be observed in other circumstances where patients are at risk of self-contamination with fecal material.