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

N/ACompletedNCT01799239

Coloplast A/S32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma

Interventions

Test productDEVICE

The test product consists of an adhesive with a new top film

SenSuraDEVICE

SenSura is the CE-marked and commercially available comparator product

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Skövde Hospital

Skövde, Sweden

Outcomes

Primary Outcomes

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 had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)

Time frame: After each baseplate change over a period, of 7 days

Data from ClinicalTrials.gov

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