ConvaTec, a leading global medical products and technologies company, today announced results from a multinational study that found Moldable TechnologyT 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. 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. By contrast, the study found more than 95 percent of new ostomy patients who started on Moldable Technology kept their skin healthy.

“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.

• 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).
• More than 97 percent of new ostomates rated the comfort of the moldable device as good or excellent.

“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.”

About the Study

The multinational observational study evaluated peristomal skin conditions in 561 ostomates using a ConvaTec Moldable TechnologyT 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, one month and two months after baseline. Peristomal skin condition was assessed using the SACST 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.