Large Scale Study Results Show ConvaTec Moldable Technology™ Skin Barriers Help to Prevent and Improve Peristomal Skin Issues in Ostomy Patients
Presented at 44th Annual Conference of the Wound, Ostomy and Continence Nurses (WOCN) Society
CHARLOTTE, NC (June 11, 2012) - ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced 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 final study results were presented at the 44th Annual Conference of the Wound, Ostomy and Continence Nurses (WOCN) Society in Charlotte, NC.
In one arm of the study, titled OSMOSEA, more than 95 percent (95.4%, N=305) of new stoma patients started on ConvaTec Moldable Technology™ Skin Barriers still had normal skin after two months. In the second study arm of existing ostomates wearing traditional skin barriers with pre-existing skin conditions, more than 88 percent (88.5%, N=140) had improved skin within two months after switching to ConvaTec Moldable Technology™ Skin Barriers.
Overall, patients in both arms of the study indicated a very high level of satisfaction with ConvaTec Moldable Technology™ Skin Barriers. Among new stoma patients, more than 90 percent (90.8%) rated the skin barrier as excellent or good. Among existing ostomates and those with pre-existing skin conditions, 85 percent rated the skin barrier as excellent or good. The performance of the skin barrier was rated highly by patients for ease of use, security and comfort. At the end of the study, 95 to 90 percent of patients, in the first and second arms respectively, reported they would recommend ConvaTec Moldable Technology™ Skin Barriers to other ostomy patients.
"Peristomal skin disorders are a common yet, as our study demonstrated, largely preventable issue for people with an ileostomy or colostomy," said lead investigator Daniéle Chaumier, ET Nurse, Hôpital Tenon, Paris, France. "With proper care and training on stoma management, and the selection of the right skin barrier, people living with an ostomy can enjoy a better quality of life than many currently do at this time."
ConvaTec Moldable Technology™ Skin Barriers with Rebounding Memory Technology™ are the only skin barriers with a patented 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 skin1,2
About the OSMOSE* Study
The observational, prospective study 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: Group A) patients using ConvaTec Moldable Technology™ Skin Barriers as their first system after surgery and Group B) 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.
Case study reports of 846 colostomy and ileostomy patients were collected with 786 patients (Intent to Treat) recorded as the study population (excluding patients who did not meet study inclusion criteria). Data were analyzed for 676 patients (Per protocolB), with 481 patients in Group A, of which 268 were colostomates and 213 were ileostomates. In Group B, 195 patients were included of which 110 were colostomates and 85 ileostomates.
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 Managementi n 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.3
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.
# # #
ConvaTec Moldable Technology, SACS and Rebounding Memory Technology are trademarks of ConvaTec Inc.
© 2012 ConvaTec Inc.
- Scott V, Raasch D, Kennedy G, Heise C. Prospective assessment and classification of stoma related skin disorders. Poster presented at: 41st Annual Wound Ostomy and Continence Nurses Society Conference; June 6-10, 2009; Orlando, FL.
- Hoeflok J, Guy D, Allen S, St-Cry D. A prospective multicenter evaluation of a moldable stoma skin barrier. Ostomy Wound Manage. 2009;55(5):62-69.
- Beitz J, Ho M. Content validation of an ostomy algorithm with peristomal skin assessment (SACS) instrument. Poster presented at the 2010 Joint Conference of The Wound, Ostomy, and Continence Nurses Society and World Council of Enterostomal Therapists; June 12-16, 2010; Phoenix, AZ.
- OSMOSE Study: An evaluation of the peristomal skin condition in ostomates using Moldable Skin Barriers. Poster presented at the 44th Annual Conference of the Wound, Ostomy and Continence Nurses (WOCN) Society in Charlotte, NC; June 9-13, 2012.
- The difference between ITT population and PP population is related to deviation from protocol.