Bichat Hospital
Paris, France
NCT Number: NCT02223104
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Paris, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to one day for closed pouches and up to two days for drainable pouches.
The patient will evaluate the level of leakage under the skin protector after each removal of pouch.
A 4 scale level will be used:
Time frame: At V1 and V2 protocol visits (at day 0 and day 14)
Time frame: At each protocol visit (day 0, day 14 and day 28)
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
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Time frame: At each protocol visits (at day 0, day 14 and day 28)
Time frame: At each protocol visits (at day 0, day 14 and day 28)
BBraun Medical SAS
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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