Kinetic Concepts, Inc. announced today that ABThera Open Abdomen Negative Pressure Therapy System (ABThera OA NPT) was associated with significantly improved patient outcomes compared to traditional Barker’s vacuum-packing technique (BVPT) in trauma and surgical patients studied. Results of the observational study, “Prospective Study Examining Clinical Outcomes Associated with a Negative Pressure Wound Therapy System and Barker’s Vacuum Packing Technique” were published in the World Journal of Surgery.
In the ABTAC study, 280 trauma and surgical patients who required temporary abdominal closure (TAC) following a damage control laparotomy or treatment of either intra-abdominal hypertension or severe sepsis were enrolled from 20 sites across the US. Among patients treated with at least 48 hours of consistent TAC therapy, the rate of primary fascial closure within 30 days was 69% for the ABThera™ OA NPT group and 51% for the BVPT (p=0.03). In this same patient group, the 30-day all-cause mortality rate was 14% for patients treated with ABThera OA NPT and 30% for those treated with BVPT (p=0.01). Multivariate logistic regression analysis identified that patients treated with ABThera Therapy were 3.2 times more likely to survive up to 30 days compared to BVPT patients [(95 percent confidence interval); p=0.02] after controlling for age, severity of illness and cumulative fluid administration.
“This is the first clinical study to demonstrate a survival advantage associated with a particular temporary abdominal closure technique,” said Michael Cheatham, MD, Corporate Chairman of Surgery, Orlando Health, and lead author of the study. “Used as part of a comprehensive approach to open abdomen management, ABThera™ OA NPT was associated with a significantly lower mortality rate, increased abdominal closure rate and improved overall patient outcome.”
Leaving the abdomen open during the management of complex abdominal problems has become common practice. However, a prolonged open abdomen can result in fluid loss, infection, loss of abdominal domain, organ dysfunction and death. Clinical research has shown that removing potentially detrimental peritoneal fluid and achieving primary fascial closure are important goals when managing patients who require an open abdomen for the treatment of critical illness. The methods of TAC chosen may play an important role in patient outcomes.
“We are very excited to see the dramatic and highly significant results of this important study. This data should be a helpful guide to clinicians managing patients with an open abdomen, a complex and often life-threatening condition,” said Ron Silverman, MD, chief medical officer, KCI.
“KCI is committed to changing the practice of medicine and improving patient lives,” said Joe Woody, president & CEO, KCI. “The dramatic results shown in this important study should prove very helpful to our clinicians who manage open abdomen patients.”
The ABThera Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and 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). The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.