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Preliminary Results of a Large Scale Study Show ConvaTec Moldable Technology™ Skin Barriers Help to Prevent and Improve Peristomal Skin Issues in Ostomy Patients

June 23, 2011

Presented at the 11th Congress of the European Council of Enterostomal Therapy (ECET)

SKILLMAN, NJ (June 23, 2011) - ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced new observational study results showing that use of ConvaTec Moldable Technology™ Skin Barriers helped to maintain skin integrity and improve peristomal skin issues in stoma patients. The preliminary study results were presented at the 11th Congress of the European Council of Enterostomal Therapy (ECET) in Bologna, Italy.

"Peristomal skin integrity plays an important role in stoma management, and the selection of a skin barrier is the first line of defense in maintaining healthy skin," said lead investigator Daniéle Chaumier, ET Nurse, Hôpital Tenon, Paris, France. "The preliminary results observed in this study, conducted in routine care, show that utilizing this unique skin barrier technology can improve peristomal skin issues and prevent their occurrence."

The observational, prospective study titled OSMOSEa evaluated the progression of peristomal skin conditions in stoma patients using ConvaTec Moldable Technology™ Skin Barriers over a two month period, involving more than 100 active centers in France. The study included two arms: 1) patients using ConvaTec Moldable Technology™ Skin Barriers as their first system after surgery and 2) patients using ConvaTec Moldable Technology™ Skin Barriers as a replacement for another device due to a reported peristomal skin issue. The level of patient satisfaction and the potential impact on quality of life were also assessed.

Both sets of patients in the study were evaluated over the test period by clinicians using the SACS™ Instrument, a content-validated instrument to assess and classify peristomal skin lesions by type and location in relation to the stoma.

More than 800 colostomy and ileostomy patients were enrolled and data for more than 700 patients were analyzed. Among patients in the first arm who completed the study (N=305), most of whom had normal skin at baseline, skin integrity was maintained or improved in nearly all patients (95 percent). Among patients in the second arm who completed the study (N=140), all of whom had skin issues at baseline, nearly all patients (90 percent) were classified as having normal skin or improved pre-existing lesions by the end of the study period.

Participants who completed the final product evaluation of the study also reported very high levels of satisfaction with ConvaTec Moldable Technology™ Skin Barriers, with both groups combined providing ratings of "excellent" or "good" in excess of 80 percent across all criteria including comfort, ease of molding, ease of application and removal, level of confidence and overall evaluation.

ConvaTec Moldable Technology™ Skin Barriers with Rebounding Memory Technology™ are the only skin barriers with a patentedb tri-laminate construction that actively adjusts to the shape and contours of the stoma. ConvaTec Moldable Technology™ Skin Barriers are supported by extensive clinical experience demonstrating their ability to prevent leaks and protect the peristomal skin.1,2

About Peristomal Skin Disorders

Peristomal skin disorders and lesions are common complications affecting people living with an ostomy.3 While estimates of the incidence of peristomal skin disorders vary, a Danish study showed that these complications can appear in 45 percent of patients living with a stoma.3 Research also indicates that peristomal skin disorders negatively impact quality of life, including the psychological and social behavior of patients.4,5

About the SACS™ Instrument

The SACS™ Instrument was developed to help establish a standard universal scale for assessing and classifying peristomal lesions by type of lesion (L) and the topographical location of skin breakdown (T). Initially developed by a consensus of Italian healthcare professionals (the Studio Alterazioni Cutanee Stoma, or Study on Peristomal Skin Lesions, study group), the instrument was published in Ostomy Wound Managementin 2007; following which it was endorsed by the Italian ET association (AIOSS) and adopted in Italy. The instrument has been subsequently content validated in the U.S.6

About ConvaTec

ConvaTec is a leading developer and marketer of innovative medical technologies that have helped improve the lives of millions of people worldwide. With four key focus areas - Ostomy Care, Wound Therapeutics, Continence and Critical Care, and Infusion Devices - ConvaTec products support healthcare professionals from the hospital to the community health setting.

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ConvaTec Moldable Technology, SACS and Rebounding Memory Technology are trademarks of ConvaTec Inc.

© 2011 ConvaTec Inc.

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