Multinational Study Finds ConvaTec Moldable Technology™ Skin Barriers Help Prevent Skin Lesions in More Than 95 Percent of New Ostomates1
Vast majority of study participants also rank Moldable Technology™ high for comfort and reliability
DEESIDE, WALES (April 8, 2015) – ConvaTec, a leading global medical products and technologies company, today announced results from a multinational study that found Moldable Technology™ skin barriers highly effective in preventing peristomal skin lesions in new ostomy patients. Peer-reviewed study results were published in the December 2014 issue of Ostomy Wound Management.1
People with an ostomy have a surgically-created opening (or stoma) for the discharge of bodily waste, commonly as a result of certain cancers or bowel disease. A skin barrier, which attaches a collection pouch to the abdomen, is designed to protect the skin around the stoma.
Traditional skin barriers are cut to fit the stoma opening. Moldable Technology requires no cutting, and instead creates an elastic-like seal that “rebounds” to fit any stoma size and shape. When it comes in contact with moisture, the Moldable skin barrier is designed to swell and “turtleneck” upward to enhance the seal.
An estimated half of all ostomates develop skin complications around the stoma, and the majority of problems stem from bodily waste leaking in between the stoma and the seal.2,3 By contrast, the study found more than 95 percent of new ostomy patients who started on Moldable Technology kept their skin healthy.1
"Patients adapting to life with an ostomy face a number of challenges, but skin complications need not be an issue,” said study investigator, Mary V. Cabral, MSN, FNP-BC, CWOCN-AP, University Surgical Associates/Rhode Island Colorectal Clinic, USA. “This study suggests that Moldable Technology may help to prevent a cycle of leakage and skin breakdown, which can impact patients both physically and emotionally.”
New patients in the study reported high levels of satisfaction in the areas of comfort; ease of preparation, application and removal; and reliability.1
- More than 95 percent of new ostomates rated the skin barrier as excellent or good in all categories in the patient questionnaire (comfort, ease of preparing, ease of attaching, ease of removing and reliability).1
- More than 97 percent of new ostomates rated the comfort of the moldable device as good or excellent.1
“These large-scale study results, together with other study results, not only speak to long-term patient benefits and satisfaction but also demonstrate that Moldable Technology repeatedly achieves clinically significant reductions in peristomal skin issues,” said Steve Bishop, Vice President of R&D at ConvaTec. “Switching to Moldable Technology can improve a patient’s quality of life.”
For more information, visit www.convatec.com or call 1-800-422-8811.
About the Study
The multinational observational study evaluated peristomal skin conditions in 561 ostomates using a ConvaTec Moldable Technology™ Skin Barrier over a two-month period. The study enrolled two subsets of patients: group A (277) used the moldable barrier as the first system after stoma creation; group B (284) replaced a traditional barrier with the moldable barrier. Data was collected via case report forms at: baseline, 8-15 days, 1 month and 2 months after baseline. Peristomal skin condition was assessed using the SACS™ scale. The study was conducted at 90 centers in Germany, Poland and the USA and received approval from local regulatory authorities.
Study objectives were to assess the incidence of peristomal complications, evaluate peristomal skin condition and assess satisfaction levels with Moldable skin barriers in patients with a colostomy, ileostomy or urostomy.1
ConvaTec is a global medical products and technologies company with leading market positions in wound therapeutics, ostomy care, continence and critical care, and infusion devices. Our products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. ConvaTec has more than 8,000 employees, with 11 manufacturing sites in 8 countries, and we do business in more than 100 countries. We are owned by Nordic Capital and Avista Capital Partners.
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- Szewczyk MT, Majewska G, Cabral MV, Holzel-Piontek K. The Effects of Using a Moldable Skin Barrier on Peristomal Skin Condition in Persons with an Ostomy: Results of a Prospective, Observational, Multinational Study. Ostomy Wound Manage. 2014;60(12):16-26.
- Herlufsen P, Olsen AG, Carlsen B, et al, Ostomy skin study: a study of peristomal skin disorders in patients with permanent stomas. Br J Nurs 2006;15(16):854-862.
- Bosio G, Pisani F, Lucibello L. A Proposal for Classifying Peristomal Skin Disorders: Results of a Multicenter Observational Study. Ostomy Wound Manage. 2007; 53(9): 38-43.