Investigation of the Performance of Ostomy Base Plate

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103466
• Other study ID #: CP204OC
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: February 22, 2013
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written Informed Consent

2. Are at least 18 years old

3. Had their ileostomy for minimum 3 months with a size between 20-40 mm

4. Have mental capacity to understand study guidelines and questionnaires

5. Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.

6. Experience leakage under the base plate at least one a week

7. Are currently using a flat 2-piece base plate with mechanical coupling

8. Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study

Exclusion Criteria:

1. Pregnant or breast-feeding

2. Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.

3. Currently receiving or have within the past 2 months received radio- and/or chemotherapy

4. Currently using steroid product on peristomal skin (injections and oral treatment are accepted)

5. Currently using a convex system

6. Participating in other clinical studies or have previously participated in this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leakage Under the Base Plate	Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.	At every change of base plate	No