NCT01243294

Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.

Detailed description

Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics. The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura. The study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home. 50 healthy subjects with a colostomy will be included in the study.

Conditions

• Colostomy

Interventions

Type	Name	Description
DEVICE	SS	New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
DEVICE	SenSura	New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-11-18
• Last updated: 2011-10-07
• Results posted: 2011-06-22

Locations

1 site across 1 country: Denmark