Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868617
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2021-04-22
Brief Title:
A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
ATTRACT-I A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CP338
Brief Summary:
This investigation is a randomized controlled open-label comparative cross-over multicenter investiga-tion with two test periods In total 82 subjects will be included and randomized and each subject will have three test visits overseen by the Principal Investigator or designee Each subject will be enrolled for 2 35 -13 days in total for the entire investigation thus approximately 70 days The subjects will test the non-CE marked test product and the comparator product in randomized order
Detailed Description:
People with intestinal stomas have despite development of better stoma products problems with leakage induced peristomal skin complications which influence quality of life negatively In fact the primary cause of peristomal skin complication development is due to leakage of ostomy effluents under the adhesive bar-rier Some of the common clinical signs of peristomal skin complications include pain itching burning discoloration bleeding and wounds To overcome this Coloplast AS has developed a new baseplate which is comprised of a protective layer
This investigation is a randomised controlled open-label comparative cross-over multicentre investigation with two test periods In total 82 subjects will be included and randomised and each subject will have at least three test visits overseen by the Principal Investigator or designee Each subject will be enrolled for 2 35 -13 days thus approximately 70 days The subjects will test the non-CE marked investigational product and the comparator product in a randomised order
Before the test periods the subjects are invited for a screening visit V0 Subjects will be consented prior to any study procedures Once consented during their participation the subjects will complete three study visits V1 V2 and V3 The visits can be at the Principal Investigators clinic or in the subjects home In rare cases ie global pandemic visits can be done remotely via video conference In addition the Principal Investigator or designee will call the subjects four times during the course of the investigation to inquire if the subject has had any issues or concerns
During the test visits the subject will complete a quality of life questionnaire and discussrecord any adverse events or device deficiencies The subject will also be asked about the use and handling of the product and their preference
At every baseplate change the subjects will be asked to take photos of their stomaperistomal skin and the backside adhesive side of the used product The photos will be taken with a smartphone using the Coloplast Clinical Trial App The subject will also be asked to complete a questionnaire about their peristomal skin condition
Coloplast will provide both the investigational product and the comparator product for all subjects
If a subject experiences a problem with the investigational product during the investigation heshe should contact the investigator for advice Subjects that cannot complete a test period with the test product may choose to use their own product ie SenSura Mio for the remainder of the test period However this must be documented by the Principal Investigator
The duration of the test periods 35 -13 days and number of visits should be adequate to assess data on the skin condition of the subjects The investigational products are tested for 35 -13 days in each study period to ensure that the skin will have time to adjust to new conditions reach a steady state and for the sub-jects to test the product for an adequate number of days to give a thorough evaluation of the products
To account for a possible carry-over effect the steady state period of the treatment period begins after two weeks of product use It is anticipated that the skin will have adapted to the new product after two weeks
This investigation is a randomised controlled open-label comparative cross-over multicentre investigation with two test periods In total 82 subjects will be included and randomised and each subject will have at least three test visits overseen by the Principal Investigator or designee Each subject will be enrolled for 2 35 -13 days thus approximately 70 days The subjects will test the non-CE marked investigational product and the comparator product in a randomised order
Before the test periods the subjects are invited for a screening visit V0 Subjects will be consented prior to any study procedures Once consented during their participation the subjects will complete three study visits V1 V2 and V3 The visits can be at the Principal Investigators clinic or in the subjects home In rare cases ie global pandemic visits can be done remotely via video conference In addition the Principal Investigator or designee will call the subjects four times during the course of the investigation to inquire if the subject has had any issues or concerns
During the test visits the subject will complete a quality of life questionnaire and discussrecord any adverse events or device deficiencies The subject will also be asked about the use and handling of the product and their preference
At every baseplate change the subjects will be asked to take photos of their stomaperistomal skin and the backside adhesive side of the used product The photos will be taken with a smartphone using the Coloplast Clinical Trial App The subject will also be asked to complete a questionnaire about their peristomal skin condition
Coloplast will provide both the investigational product and the comparator product for all subjects
If a subject experiences a problem with the investigational product during the investigation heshe should contact the investigator for advice Subjects that cannot complete a test period with the test product may choose to use their own product ie SenSura Mio for the remainder of the test period However this must be documented by the Principal Investigator
The duration of the test periods 35 -13 days and number of visits should be adequate to assess data on the skin condition of the subjects The investigational products are tested for 35 -13 days in each study period to ensure that the skin will have time to adjust to new conditions reach a steady state and for the sub-jects to test the product for an adequate number of days to give a thorough evaluation of the products
To account for a possible carry-over effect the steady state period of the treatment period begins after two weeks of product use It is anticipated that the skin will have adapted to the new product after two weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None