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

NCT01799239 | Completed Results

• 1 other identifier: CP237
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ileostomy - Stoma

Keywords

stoma ileostomy

Outcome Measures

Primary Outcomes (1)

• 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)

  After each baseplate change over a period, of 7 days

Study Arms (2)

First Test product; then SenSura

EXPERIMENTAL

The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. After cross-over the subject test SenSura which is CE-marked and commerical available.

Device: Test product; Device: SenSura

First SenSura, Then Test product

ACTIVE COMPARATOR

The subject in this arm first test SenSura which is CE-marked and commerical available. After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.

Device: Test product; Device: SenSura

Interventions

Test product DEVICE

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

First SenSura, Then Test product; First Test product; then SenSura

SenSura DEVICE

SenSura is the CE-marked and commercially available comparator product

First SenSura, Then Test product; First Test product; then SenSura

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Be able to handle the bags themselves
• Have an ileostomy with a diameter between 15 and 55 mm
• Have had their ileostomy for at least 3 months
• Currently use a 1-piece flat ostomy appliance with open bag
• Use minimum 1 product every second day, i.e. maximum 2 days wear time
• Be suitable for participation in the study and for using a standard adhesive, flat base plate
• Must be able and willing to use custom cut products
• Accept to test two 1-piece products within the study period

You may not qualify if:

• Use irrigation during the study period (flush the intestines with water)
• Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
• Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
• Are pregnant or breastfeeding
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Currently using a ostomy belt
• Currently using extended wear product
• Have a loop ileostomy
• Known hypersensitivity towards any of the test products
• Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Skövde Hospital

Skövde, 541 85, Sweden

Location

Results Point of Contact

• Title: Camilla Felsvang Vibjerg, Senior Clinical manager
• Organization: Coloplast A/S

dkcfv@coloplast.com

+45 4911 1990

Study Officials

• Daniel Carter, MSc

  Coloplast A/S

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 26, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 30, 2016
• Results First Posted: December 5, 2013

Record last verified: 2016-08

Locations

SE (1)