Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2013-06-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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One piece closed pouch
One piece closed pouch
One piece closed pouch
A one piece closed pouch for the collection of stool from a colostomy stoma
Interventions
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One piece closed pouch
A one piece closed pouch for the collection of stool from a colostomy stoma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is able to read, write, and understand the primary language of the investigative site.
* Have a colostomy for more than 3 months
* Currently a one or two piece closed or drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
* Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
* Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
* Be willing to wear a one piece closed pouch with moldable wafer according to the usual wear pattern of this type of pouch
* Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
* Be willing to remain in residence for 3 days at a central location
* Be willing to meet with the investigator for a total of nine scheduled visits.
* Be willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device
* Other than their colostomy considered to have a healthy/stable health status
* Have good manual dexterity and be able to take care of their stoma independently
* Be willing and able to complete a diary card for the duration of the study.
* Be willing to take photographs of the stoma and pouch on pouch removal
Exclusion Criteria
* Subjects with stoma duration of less than 3 months
* Subjects who currently use a belt with their usual appliance
* Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
* Subjects who require convexity or other skin fillers (pastes, seals, or rings) to even undulations of the peristomal skin
* Subjects undergoing chemotherapy or radiotherapy
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
18 Years
ALL
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Popovich-Durnal, RN BSN
Role: PRINCIPAL_INVESTIGATOR
Unafilliated
Locations
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Independent Nurse Consultants LLC
Tucson, Arizona, United States
Countries
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Other Identifiers
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CC-0512-13-A741
Identifier Type: -
Identifier Source: org_study_id