Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

Ileostomy - Stoma Clinical Trial

Official title:

Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799239
• Other study ID #: CP237
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: October 7, 2013
• Start date: February 2013
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written informed consent

2. Be at least 18 years of age and have full legal capacity

3. Be able to handle the bags themselves

4. Have an ileostomy with a diameter between 15 and 55 mm

5. Have had their ileostomy for at least 3 months

6. Currently use a 1-piece flat ostomy appliance with open bag

7. Use minimum 1 product every second day, i.e. maximum 2 days wear time

8. Be suitable for participation in the study and for using a standard adhesive, flat base plate

9. Must be able and willing to use custom cut products

10. Accept to test two 1-piece products within the study period

Exclusion Criteria:

1. Use irrigation during the study period (flush the intestines with water)

2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy

3. Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area

4. Are pregnant or breastfeeding

5. Participating in other interventional clinical investigations or have previously participated in this investigation

6. Currently using a ostomy belt

7. Currently using extended wear product

8. Have a loop ileostomy

9. Known hypersensitivity towards any of the test products

10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

Study Design

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

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Test product
The test product consists of an adhesive with a new top film
• SenSura
SenSura is the CE-marked and commercially available comparator product

Locations

Country	Name	City	State
Sweden	Skövde Hospital	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leakage (Percentage of All Baseplates With Leakage)	leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.; The subjects tick of one of the four possible answers: No leakage; Starting to leak; Leakage; Sudden leakage	After each baseplate change over a period, of 7 days	No