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ADVOCATE Study Is The First to Provide Health And Economics Outcomes Data on The Clinically Meaningful Implications of The Use of CeraPlusTM skin barrier
LIBERTYVILLE, Ill., Jan. 19, 2018 /PRNewswire/ -- Hollister Incorporated, a global medical device manufacturer, today announced that its ADVOCATE (A Randomized Controlled Trial Determining the Variances in Ostomy Skin Conditions And The Economic Impact) study demonstrated that CeraPlus skin barrier, an ostomy skin barrier infused with ceramide, has a positive impact on stoma-related cost of care and peristomal skin health. The results were published in the January/February issue of the Journal of Wound, Ostomy and Continence Nursing (JWOCN), the peer-reviewed publication of the Wound, Ostomy and Continence Nurses Society.
"These data provide significant insights into how proactively managing peristomal skin health with a ceramide-infused skin barrier may result in better outcomes for those living with ostomies," said Joyce Pittman, PhD, RN, NP, CWOCN, co-author of the study and Adjunct Assistant Professor at Indiana University School of Nursing. "Peristomal skin complications can be a painful, vicious cycle, and patients are at higher risk for developing complications during the first 12 weeks after stoma surgery. Based on these findings, we have the opportunity to promptly address these complications in our overall care and treatment plans, to help positively impact the lives of individuals living with ostomies."
CeraPlus skin barrier users in the ADVOCATE study experienced a clinically meaningful reduction in the occurrence of peristomal skin complications (PSCs) and PSCs were significantly more likely to resolve in a 4-week period with the use of CeraPlus skin barriers. Individuals using CeraPlus skin barriers experienced a 26.9 percent relative reduction in PSCs in comparison to those using Hollister Ostomy Care non-ceramide barriers, although the difference was not statistically significant. Significantly more participants were 'very satisfied' with the overall barrier performance as compared to the Hollister Ostomy Care non-ceramide barrier control group.
"We know that peristomal skin complications affect the majority of people living with stoma, and present a significant burden in terms of quality of life, as well as higher overall healthcare costs for the healthcare system and the patients it serves," said Janice Colwell, RN, MS, CWOCN, FAAN, co-author of the study and the Advanced Practice Nurse in Wound and Ostomy Care at the University of Chicago Medicine. "The results of the ADVOCATE study show that a skin barrier infused with ceramide can have a positive impact on both patient outcomes and economic burden, by reducing the incidence of peristomal skin complications, and significantly reducing the stoma-related cost of care."
The ADVOCATE study demonstrated a statistically significant cost savings utilizing CeraPlus skin barriers over the 12-week period, as compared to the Hollister Ostomy Care non-ceramide control group. The use of CeraPlus skin barriers resulted in a 14 percent relative reduction in stoma-related cost of care (supplies and select accessories, topical treatments and healthcare visits).
Approximately 800,000 people are currently living with an ostomy and about 120,000 stoma surgeries are performed annually in the U.S. and Canada.1,2 PSCs are common for people living with stoma and occur for a variety of reasons, primarily due to leakage from the stoma, resulting in skin irritation.3,4,5,6,7 While the total cost of ostomy care is difficult to evaluate, PSCs necessitate additional products, accessories and topical medications as well as increased usage of supplies, clinic visits and other healthcare services which increases the cost of care.8
The rigorously designed ADVOCATE study, a multi-centered randomized, controlled and double-blinded international study, included 153 adults from 25 sites in the U.S., Canada and Europe, who were seen in hospital and outpatient care settings between March 2015 and January 2017. The study compared Hollister Ostomy Care's CeraPlus skin barrier against Hollister Ostomy Care barrier products without ceramide to examine the differences in ostomy skin barriers and their impact on costs of stoma care and occurrence of PSCs. The primary objective was to compare stoma-related costs for skin barriers containing ceramide (treatment) to skin barriers without ceramide (control). The secondary objective was to compare the incidence of PSCs for the two groups. Quality of life and patient-reported outcomes were also analyzed, including ease of product removal, satisfaction with wear time, prevention of leakage and itching, as well as overall satisfaction with the skin barrier.
About CeraPlus skin barrier
CeraPlus skin barrier is an ostomy skin barrier infused with ceramide, which is a natural component of human skin that helps prevent moisture loss which can lead to skin dryness and damage. It is designed to maintain adhesive properties, and features a formulation to maintain good peristomal skin health and decrease transepidermal water loss from damaged or eroded skin. The CeraPlus skin barriers are available in both flat and soft convex skin barrier design options to ensure a secure and flexible fit regardless of patient body type. More information on CeraPlus skin barrier can be found at http://www.hollister.com/en/CeraPlus skin barrier.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and wound care, and also develops educational support materials for patients and healthcare professionals. Hollister Incorporated has been serving healthcare professionals and consumers for more than 95 years, and is committed to making life more rewarding and dignified for people who use its products and services. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in more than 80 countries around the world. More information can be found at www.Hollister.com.
1 United Ostomy Associations of America. 2017. New ostomy patient guide. http://www.ostomy.org/ Accessed 8/30/17.
2 Turnbull G. The Ostomy Files: Ostomy Statistics: The $64,000 Question. Ostomy Wound Manage. 2003;49(6):22 23. http://www.o-wm.com/article/1756. Accessed June 2003.
3 Colwell J, Goldberg, M., Carmel, J. The state of the standard diversion. J Wound Ostomy Continence Nurs. 2001;28:6-17.
4 Persson E, Gustavsson, B., Hellstrom, A., Lappas, G., Hulten, L. Ostomy patients' perceptions of quality of care. J Advanced Nurs. 2005;49(1):51-58.
5 Ratliff C, Scarano, K., Donovan, A. Descriptive study of peristomal complications. J Wound Ostomy Continence Nurs. 2005;32(1):33-37.
6 Salvadalena G. The incidence of stoma and peristomal complications during the first 3 months after ostomy creation. J Wound Ostomy Continence Nurs. 2013;40(4):400-406.
7 Nybaek H, et al. Skin Problems in Ostomy Patients: A Case Control Study of Risk Factors. Acta Derm Venereol. 2009; 89:64-67.
8 Smith AJ, Lyon CC, Hart CA. Multidisciplinary care of stoma problems in stoma patients. Br J Nurs. 2002;11(5):324-330.
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