Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy

BBraun Medical SAS38 enrolled

Overview

To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Enterostomy

Interventions

Flexima 3SDEVICE

Flexima 3S (2-piece appliance) with drainable pouch

New 2-piece ostomy applianceDEVICE

New 2-piece ostomy appliance with drainable pouch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient having a colostomy or an ileostomy for at least 1 month * patient currently using a flat appliance * patient wearing his appliance, on average, at least 5 days * patient with a stoma's diameter less than 65 mm * patient who agrees to participate in the evaluation and who have signed the inform consent * patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions) Exclusion Criteria: * Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion) * Patient receiving or having received, within the last month, chemotherapy or corticotherapy * Patient already participating in another clinical study or who have previously participated in this investigation * Pregnant or breast-feeding woman

Locations (2)

Hospital Selayang

Batu Caves, Malaysia

RECRUITING

Hospital Canselor Tuanku Muhriz

Kuala Lumpur, Malaysia

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period

For each base plate, the wear time will be evaluated during 21 (±3) days

Time frame: On average every 5 days, up to 21 (±3) days for each period

Secondary Outcomes

Assessment of the condition of peristomal skin

Using a standardized measuring ostomy skin tool

Time frame: After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days)

Assessment of the main reason of base plate removal

After each base plate removal, the patient will describe on a 7-point scale the main reason of base plate removal ("habit", "hygiene", "leakage under the base plate", "unsticking of the base plate periphery", "unsticking of the base plate, not only on the periphery", "ask for the study but the base plate could stay longer in place", "other, to specify". No value is considered as the better outcome, it's only descriptive value.

Time frame: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period

Assessment of acceptability

At the end of each study period (21 (±3) days), the patient will assess on a 4-point scale each parameter of acceptability ("very good", "good", "bad", "very bad". The "very good" value is considered as the better outcome.

Time frame: At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days)

Assessment of use of accessories

After each base plate removal, the patient will describe on a 8-point scale the use of accessories ("none", "protective spray", "powder", "paste", "ring", "adhesive remover", "belt", "other, to specify". No value is considered as the better outcome, it's only descriptive value.

Central Contacts

Aude Michaud

CONTACT

+33632542788 aude.michaud@bbraun.com

Data from ClinicalTrials.gov

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