NCT01103466

Investigation of the Performance of Ostomy Base Plate

A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.

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 base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems. The purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market. The study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home. 80 healthy participants with an ileostomy will be included in the study.

Conditions

• Ileostomy - Stoma

Interventions

Type	Name	Description
DEVICE	Atlas	Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
DEVICE	SenSura	SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
DEVICE	Conform 2	Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-04-14
• Last updated: 2013-04-04
• Results posted: 2013-04-04

Locations

1 site across 1 country: Denmark