August 21, 2017
PREVENA™ Incision Management System Shown to Reduce Incisional Pain and Associated Narcotic Use Among Obese Study Patients Undergoing Cesarean Delivery
Study results indicate patients utilizing the PREVENA™ Incision Management System had a 30 percent decrease in opioid use during post-operative recovery and reduced surgical site occurrences
SAN ANTONIO, August 21, 2017 – Recent results published in the American Journal of Perinatology demonstrated the reduction of post-surgical wound complications in obese patients undergoing cesarean delivery with closed incision negative pressure therapy (ciNPT) using the PREVENA™ Incision Management System. The paper titled, “Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial,” found that patients had a significant reduction in post-operative pain and narcotic use and experienced reduced surgical site occurrences (SSOs) when receiving ciNPT compared to standard-of-care (SOC) dressing.
“This compelling new data suggests that negative pressure wound therapy may be used to reduce post-operative pain in surgical patients,” said Ron Silverman, M.D., F.A.C.S., Chief Medical Officer, Acelity. “By examining patients at greater risk of complications and increased costs in this study, we can now point to definitive, exciting data that shows PREVENA™ Therapy improves the patient experience by reducing pain. This study adds to the growing body of evidence that demonstrates a potential reduction in post-operative wound complications in a variety of surgical incisions.”
According to the National Center for Health Statistics, there were more than 1.2 million cesarean deliveries in the United States in 2015.1 Approximately two to seven percent of cesarean deliveries result in a SSO, leading to prolonged wound healing, postoperative pain, increased rates of secondary infection and re-hospitalization, decreased patient satisfaction, and increased costs of medical care. A typical hospital readmission costs approximately $6,600 for a post-cesarean SSO. Obese women who undergo cesarean delivery are at particular risk, as several studies have demonstrated higher rates of wound infection among this population.2,3
“Cesarean deliveries are the most commonly performed surgical procedure in the United States, and post-cesarean wound complications, specifically in pregnant women who are obese, remain a major issue in modern obstetrics,” said Robert Phillips Heine, M.D., study author, Duke University Medical Center. “While further research is needed, these results have significant implications for postpartum and postoperative pain management as the evidence indicates that closed incision negative pressure therapy could provide alternatives to traditional medications that are typically used to mitigate pain at the incision site.”
The single-center, randomized, controlled study compared SSOs, such as unanticipated local inflammatory response, prolonged drainage, fluid collection, dehiscence, and surgical site infection, in 82 patients undergoing cesarean delivery receiving ciNPT with the PREVENA™ Incision Management System or SOC dressing. The results indicated that the ciNPT group, when compared to SOC group were as follows:
Fewer SSOs (5.1% vs. 16.3%; p=.16, did not reach statistical significance)
Less incisional pain both at rest (43.5% vs. 84.8%; p<.001) and with incisional pressure (54.3% vs. 91.3%; p<.001)
30% decrease in total opioid use (55.9 mg morphine vs. 79.1 mg; p=.036)
About PREVENA™ Incision Management System
The PREVENA™ System, launched in 2010, is the first disposable negative pressure system designed specifically for the management of closed surgical incisions. The system covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision. Please refer to the Instructions for Use for the PREVENA™ Systems for a complete list of appropriate uses, warnings, and precautions.
Acelity L.P. Inc. and its subsidiaries are a global advanced wound care company that leverages the strengths of Kinetic Concepts, Inc. and Systagenix Wound Management, Limited. Available in more than 90 countries, the innovative and complementary ACELITY™ product portfolio delivers value through solutions that speed healing and lead the industry in quality, safety and customer experience. Headquartered in San Antonio, Texas, Acelity employs nearly 5,000 people around the world.
1. Brahmbhatt, R., Carter, S. A., Hicks, S. C., Berger, D. H., & Liang, M. K. (2014). Identifying Risk Factors for Surgical Site Complications after Laparoscopic Ventral Hernia Repair: Evaluation of the Ventral Hernia Working Group Grading System. Surgical Infections , 15, 187-193. Retrieved July 27, 2017, from http://online.liebertpub.com/doi/pdf/10.1089/sur.2012.179
2. Perlow JH, Morgan MA, Montgomery D, Towers CV, Porto M. Perinatal outcome in pregnancy complicated by massive obesity. Am J Obstet Gynecol 1992;167(4 Pt 1):958–962
3. Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol 2008;29(06):477–484, discussion 485–486