Separate Independent Studies Found that PREVENA™ Therapy Reduced Complications Following Breast Cancer Surgery and Breast Reconstruction

KCI, an Acelity Company, announced today that recently published data stemming from two studies demonstrate that closed incision negative pressure therapy (ciNPT) with the PREVENA™ Incision Management System reduced postsurgical wound complication potential in patients recovering from oncological breast surgery and breast reconstruction, respectively.

One study titled, “The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes,” showed that patients who received ciNPT with the PREVENA™ System had significantly lower rates of overall complications and returns to the operating room compared to those in the standard of care (SOC) for incision management after breast reconstruction post-mastectomy group. In addition, patients in the PREVENA™ Therapy group overall had a shorter mean time to complete removal of all drains than the SOC group, averaging 9.9 days versus 13.1, respectively.¹

In a separate study titled, “Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings,” researchers found that patients in the PREVENA™ Therapy group showed significantly lower postsurgical complication rates, demonstrating 4 percent in the PREVENA™ Therapy group versus 45 percent in the SOC group.²

“Minimizing the risk of complications for the patients in my care is of the utmost importance to me as a practicing plastic surgeon, and this recent data adds to the established body of evidence that demonstrates the ability of PREVENA™ Therapy to help preserve outcomes for breast reconstruction patients,” said Ron Silverman, M.D., F.A.C.S., Chief Medical Officer, KCI, an Acelity Company. “Further, this data has implications for lowering healthcare costs and improving quality and the patient experience as post-operative complications create a tremendous burden impacting patients, surgeons and payers. At KCI, we are dedicated to bringing to market innovations that address these needs supported by proven-real world results that improve patients’ lives.”

The American Cancer Society estimated that in 2017, there were more than 252,710 new invasive breast cancer cases in the United States. Breast reconstruction among women in the United States undergoing mastectomy has increased from 12 percent in 1998 to 36 percent in 2011.³ Postoperative infection remains the most common and likely the most feared complication from breast reconstruction surgery, which can often cost an additional $10,000 or more.^4,5

Study Overviews

“The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes:”

• A single site, retrospective review of records for 356 adult female patients who underwent breast reconstruction post-mastectomy was conducted. Records were divided into two groups for comparative analysis: patients who received SOC versus patients who received ciNPT with the PREVENA™ Incision Management System for closed incision management post breast reconstruction.

“Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings:”

• In a study of 37 patients undergoing oncological breast surgery, 17 patients (25 surgeries) received ciNPT with the PREVENA™ Incision Management System and the remaining 20 patients (20 surgeries) had SOC.

Both studies were published in Plastic and Reconstructive Surgery - Global Open.

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.

About Acelity, Inc.

Acelity, Inc. is a global advanced wound care company committed to developing innovative healing solutions for customers and patients across the care continuum. Its subsidiary, KCI, is a well trusted brand in advanced wound care. KCI’s solutions are available in more than 90 countries and deliver value through solutions by speeding healing. KCI is a leader in quality, safety and customer experience and is committed to advancing the science of healing, KCI sets the standard for leading advanced wound therapy innovation.

¹ Gabriel A, Sigalove S, Sigalove N, Storm-Dickerson T, Rice J, Maxwell P, Griffin L. The impact of closed incision negative pressure therapy on postoperative breast reconstruction outcomes. Plast Reconstr Surg Glob Open. 2018 Aug; 6(8):e1880.

² Ferrando PM, Ala A, Bussone R, Bergamasco L, Perinetti FA, Malan F. Closed incision negative pressure therapy in oncological breast surgery: Comparison with standard care dressings. Plast Reconstr Surg Glob Open. 2018;6(6):e1732.

³ American Cancer Society, “Breast Cancer Facts and Figures 2017-2018.” Retrieved from https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2017-2018.pdf.

⁴ Kim JY, Davila AA, Persing S et al. A meta-analysis of human acellular dermis and submuscular tissue expander breast reconstruction. Plast Reconstr Surg 2012;129:28-41.

⁵ Susman, Ed. Post-Mastectomy Breast Reconstruction and Complications Swell Costs. Oncology Times 2016; 38:3.

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Contact information

Acelity
Maggie Fairchild
Corporate Communications
Phone: +1-210-330-2666
Email: maggie.fairchild@acelity.com
or
Jathan Tucker
Investor Relations
Phone: +1-210-255-6816
Email: jathan.tucker@acelity.com