Abstract Published in Canadian Journal of Surgery Reports Key Preliminary Findings of Major Prospective Study of the KCI ABThera™ Open Abdomen Negative Pressure Therapy System
Kinetic Concepts, Inc. announced today that an abstract referring specifically to the KCI ABThera™ Open Abdomen Negative Pressure Therapy System (ABThera™ OA NPT), states that this "prospective cohort study observed a reduction in mortality (RR 0.48, 95% CI 0.25-0.92) and an increased fascial closure rate (RR 1.5, 95% CI 1.1 – 2.0) in patients who received the ABThera™ versus [Barker's technique] vacuum pack."
SAN ANTONIO—April 17, 2012— Kinetic Concepts, Inc. announced today that an abstract referring specifically to the KCI ABThera™ Open Abdomen Negative Pressure Therapy System (ABThera™ OA NPT), states that this "prospective cohort study observed a reduction in mortality (RR 0.48, 95% CI 0.25-0.92) and an increased fascial closure rate (RR 1.5, 95% CI 1.1 – 2.0) in patients who received the ABThera™ versus [Barker's technique] vacuum pack."
This data was presented in greater detail at the 2011 World Congress of Abdominal Compartment Syndrome (WCACS). The presentation described this KCI-funded on-label study, called ABTAC, which was a prospective, observational, open-label parallel study performed to evaluate two temporary abdominal closure (TAC) techniques: ABThera™ OA NPT and the Barker's vacuum-packing technique. There were 280 study participants enrolled from 20 participating hospitals in the United States. Participants consisted of trauma and surgical patients who required TAC following a damage control laparotomy or treatment of either intra-abdominal hypertension or severe sepsis. A smaller subset of the study population (138 patients) received at least 48 hours of consistent TAC therapy with either ABThera™ OA NPT (n=94) or the Barker's vacuum-packing technique (n=44). The two groups were analyzed in terms of age, BMI, SOFA, APACHE III, and ISS scores (three well-established severity of illness grading scales) with no statistically significant differences detected across these variables.
Two important outcome measures from ABTAC were rate of primary fascial closure (primary measure) and 30-day All-Cause Mortality rate (secondary measure). Among the patients treated with at least 48 hours of consistent TAC therapy, the rate of primary fascial closure (within 30 days) was 76% for the ABThera™ OA NPT group and 57% for the Barker's vacuum-packing technique (p=0.03). In this same patient group, the 30-day All-Cause Mortality rate was 15% for patients treated with ABThera™ OA NPT and 34% for those treated with Barker's vacuum-packing technique (p=0.01).
The abstract, was also presented at the 2012 Trauma Association of Canada Annual Scientific meeting on April 13, 2012.
The ABThera™ Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. This system is intended for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome (ACS).
For more information about KCI please visit www.kci1.com.
Kinetic Concepts, Inc. is a leading global medical technology company devoted to the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound care and therapeutic support system markets. Headquartered in San Antonio, Texas, KCI has significantly advanced the science of wound healing over the course of more than three decades. KCI's success can be traced to a history deeply rooted in innovation and a passion for significantly improving patient outcomes while reducing the overall cost of care for patients around the world. KCI's proprietary negative pressure technologies have revolutionized the way in which caregivers treat a wide variety of wound types. The V.A.C.® Therapy System has been used on more than 6 million wounds worldwide. Additional information about KCI and its products is available at www.KCI1.com.
- D. Roberts, D. Zygun, J. Grendar, C. Ball, H. Robertson, J.-F. Ouelet, M. Cheatham, and A. Kirkpatrick, "Negative pressure wound therapy for critically ill adults with open abdominal wounds: a systematic review," Canadian Journal of Surgery, April 2012; Vol. 55, Suppl.
- M. Cheatham, "ABTAC-50 study: ABThera vs. Barker Vacuum Pack Dressing," 5th World Congress of Abdominal Compartment Syndrome, Lake Buena Vista, Florida, August 12, 2011