One Piece Closed Pouch in Subjects With a Colostomy

Completed · Phase 2

Conditions studied: Colostomy

In brief

A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.

Key facts

Study ID

NCT01935999

Run by

ConvaTec Inc.

People needed

11

Starts

2013-06-01

Expected to finish

2013-07-01

Last updated by the study team

2013-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Independent Nurse Consultants LLC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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