New Independent Study Results Add to Growing Body of Evidence That PREVENA™ Therapy Helps Reduce Surgical Site Infections and Complications

Study concludes that total arthroplasty patients treated with PREVENA^™ Therapy were four times less likely to experience surgical site complications compared with traditional gauze dressing

SAN ANTONIO--(BUSINESS WIRE)--New independent data recently published in the Journal of Arthroplasty further demonstrates the body of expanding clinical evidence that closed incision negative pressure therapy (ciNPT) with the PREVENA™ Incision Management System reduces post-surgical wound complication potential. Results of a recent trial of nearly 600 patients undergoing total joint replacement illustrated the benefits of the PREVENA™ Incision Management System in reducing several surgical site complications. Patients in the study treated with PREVENA™ Therapy had statistically significant lower rates of overall infection, and were four times less likely to experience a surgical site complication.

“These results are significant as this is one of the largest observations of negative pressure wound therapy use in clean closed surgical incisions and demonstrate the potential for the use of ciNPT to improve patient outcomes and reduce system-wide costs,” said Karl J. Beer, M.D., study investigator and orthopedic surgeon at ProMedica Toledo Hospital, Toledo, Ohio. “Total knee and total hip arthroplasty are two of the most common orthopedic procedures performed in the United States, and because they are often conducted in an aging population with comorbidities, they frequently lead to post-operative complications. This data suggests that ciNPT should be routinely used following these surgeries to potentially prevent wound site complications.”

The study titled, “Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty,” evaluated the efficacy of the PREVENA™ Incision Management System in reducing the rates of surgical complications following total knee arthroplasty (TKA) and total hip arthroplasty (THA). Surgical site complications in arthroplasty procedures represent a severe burden to the healthcare system because they often lead to revision surgeries and substantially increased economic cost for patients.^1,2,3 Data shows that patients requiring early surgical treatment for wound healing problems after total joint replacement are 7.5 times more likely to develop further complications, such as deep infection and major subsequent surgery. ⁴

“PREVENA™ Therapy continues to demonstrate the ability to reduce the rate of post-operative incision related complications across a variety of surgical specialties, including vascular surgery, cardiac surgery, general surgery, plastic surgery, OB-GYN, orthopedic trauma, and now total joint replacement surgery,” said Ron Silverman, M.D., F.A.C.S., Chief Medical Officer, Acelity. “We want our surgeon customers who serve on the front lines of care to feel as confident as possible in their outcomes. The growing body of clinical evidence clearly supports PREVENA™ Therapy’s ability to preserve their work and improve the healing process for their patients.”

The number of TKAs and THAs continue to increase annually given the country’s growing population of older Americans.^5,6,7 More than one million knee replacements and 900,000 total hip replacements are anticipated in 2017.⁸ Given the older population, patients are more likely to have chronic diseases such as diabetes, cardiovascular disease or rheumatoid arthritis, which increase the risk of surgical wound complications.^5,6,7

Study Overview

A single center, open-label study with a prospective cohort of 192 patients undergoing primary TKA or THA treated with ciNPT of clean surgical wounds was conducted. One hundred ninety-six incisions treated with the PREVENA™ Incision Management System were compared with a historical control group of four hundred patients that had incisions treated with traditional gauze dressing. Results demonstrate that, with the PREVENA™ Incision Management System, patients presented:

• Significantly decreased overall rates of infection (including superficial wound infection) (3.5% vs 1.0%, p=0.04)
• Lower overall complication rate (1.5% vs 5.5%, p=0.02)
• Four times less likelihood of experiencing a surgical site complication compared with control (p=0.0277, odds ratio 4.251, 95% confidence interval 1.172-15.414)
• Lower pain score at 24 hours post op (p<.0001)

About PREVENA^TM 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.

Most recently, Acelity has launched three new products in the PREVENA™ Therapy family. The PREVENA PLUS™ 125 Therapy Unit as an individual product provides a disposable, “a la carte” option compatible with all PREVENA™ Incision Dressings. The new PREVENA PLUS^TM PEEL & PLACE^TM Incision Management System – 35cm provides customers with an easy to use dressing designed to address linear incisions up to 35cm in length and provides higher exudate storage capacity. In addition, the new PEEL & PLACE™ Dressing 5 Pack – 35cm can be utilized for patients that remain in the hospital for a few days post-surgery.

About Acelity

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.

References

1. Burns AW, Bourne RB, Chesworth BM, MacDonald SJ, Rorabeck CH. Cost effectiveness of revision total knee arthroplasty. Clin Orthop Relat Res. 2006;446:29-33.
2. Oduwole KO, Molony DC, Walls RJ, Bashir SP, Mulhall KJ. Increasing financial burden of revision total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2010;18:945-8.
3. Ong KL, Mowat FS, Chan N, Lau E, Halpern MT, Kurtz SM. Economic burden of revision hip and knee arthroplasty in Medicare enrollees. Clin Orthop Relat Res. 2006;446:22-8.
4. Galat DD, McGovern SC, Larson DR, Harrington JR, Hanssen AD, Clarke HD. Surgical treatment of early wound complications following primary total knee arthroplasty. J Bone Joint Surg Am 2009;91:48-54.
5. Jones RE. Wound healing in total joint arthroplasty. Ortho. 2010;33:660.
6. Raikin SM, Kane J, Ciminiello ME. Risk factors for incision-healing complications following total ankle arthroplasty. J Bone Joint Surg Am. 2010;92:2150-5.
7. Zmistowski B, Restrepo C, Kahl LK, Parvizi J, Sharkey PF. Incidence and reasons for nonrevision reoperation after total knee arthroplasty. Clin Orthop Relat Res. 2011 Jan;469(1):138-45.
8. Life Science Intelligence Data on File.