One Piece Closed Pouch in Subjects With a Colostomy

Recruitment & Eligibility

Inclusion Criteria

Of legal consenting age and able to provide written informed consent
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 a history of sensitivity to any one of the ostomy products or the components being studied
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

Study & Design

Arm && Interventions

Group	Intervention	Description
One piece closed pouch	One piece closed pouch	One piece closed pouch

Primary Outcome Measures

Name	Time	Method
Safety	10 days - duration of study period	Safety in relation to type and number of adverse events, condition of the skin surrounding the colostomy stoma and condition of the stoma

Secondary Outcome Measures

Name	Time	Method
Performance/Efficacy	10 days duration of study period	Performance/Efficacy of the pouch to stay in place and collect stool from the stoma. Ease of use, security will be assessed

Recruitment & Eligibility