Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy

Colostomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223104
• Other study ID #: OPM-G-H-1301
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2013
• Last updated: July 30, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient is at least 18 years old

• patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches

• patient having a colostomy for at least 1 month

• patient using currently a one-piece flat ostomy appliance with closed or drainable bags

• patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches

• patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)

• patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)

• patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and Sensura® (size midi or maxi, beige) during 14 days

• patient covered by social security

Exclusion Criteria:

• patient receiving or having received, within the last month, chemotherapy or radiotherapy

• patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)

• patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin

• patient already participating in another clinical study or who have previously participated in this investigation

• pregnant or breast-feeding woman

Study Design

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

Related Conditions & MeSH terms

• Colostomy

Intervention

Device:
• Flexima Active

• Sensura

Locations

Country	Name	City	State
France	Bichat Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.	The patient will evaluate the level of leakage under the skin protector after each removal of pouch.; A 4 scale level will be used: "no leakage under the skin protector",; "leakage under the skin protector not soiling clothes",; "leakage under the skin protector soiling clothes",; "sudden and massive leakage under the skin protector".	Up to one day for closed pouches and up to two days for drainable pouches.	No
Secondary	Assessment of the condition of peristomal skin		At V1 and V2 protocol visits (at day 0 and day 14)	No
Secondary	Acceptability of each pouch	Acceptability is defined by those criteria: Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance	At each protocol visit (day 0, day 14 and day 28)	No
Secondary	Preference between Flexima® Active and Sensura®		At each protocol visits (at day 0, day 14 and day 28)	No
Secondary	Assessment of the quality of life with Stoma-QoL questionnaire		At each protocol visits (at day 0, day 14 and day 28)	No
Secondary	Adverse(s) Event(s)		At each protocol visits (at day 0, day 14 and day 28)	Yes