Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-28 @ 5:11 AM
Study NCT ID:
NCT01103466
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of the Performance of Ostomy Base Plate
Sponsor:
Coloplast A/S
Organization:
Study Overview
Official Title:
A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: