One Piece Drainable Pouch in Subjects With an Ileostomy

A Single Center Study to Assess the Safety and Performance of a One Piece Drainable Pouch in Subjects With an Ileostomy

To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.

Study Overview

• Status: Completed
• Conditions: Ileostomy
• Intervention / Treatment: Device: One Piece Drainable Pouch

Detailed Description

This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85742
      • Independent Nurse Consultant LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Of legal consenting age and able to provide written informed consent
2. Is able to read, write, and understand the primary language of the investigative site.
3. Have an ileostomy for more than 3 months
4. Currently a one or two piece drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
5. Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
6. Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
7. Be willing to wear a one piece drainable pouch with moldable wafer according to the usual wear pattern of this type of pouch
8. Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
9. Be willing to remain in residence for 3 days at a central location
10. Be willing to meet with the investigator for a total of nine scheduled visits.
11. 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
12. Other than their ileostomy 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 - The following subjects must not be included into the study:

1. Subjects with a history of sensitivity to any one of the ostomy products or the components being studied
2. Subjects with stoma duration of less than 3 months
3. Subjects who currently use a belt with their usual appliance
4. Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
5. Subjects who require convexity or other skin fillers (pastes, seals, or rings) to even undulations of the peristomal skin
6. Subjects undergoing chemotherapy or radiotherapy
7. Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: One Piece Drainable Pouch; This is a one piece drainable pouch designed for the purpose of collecting stool from subjects with an ileostomy stoma	Device: One Piece Drainable Pouch; Other Names: Enhanced one piece drainable pouch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	To assess the condition of the peristomal skin and stoma and number and frequency of adverse events	Study duration will be 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance/Efficacy	To assess ease of use including ease of application and removal, comfort and security along with wear time	The study will be for 10 days

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Ann Popavich-Durnal, RN BSN

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 29, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 11, 2013

Study Record Updates

• Last Update Posted (Estimate): September 11, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Ileostomy; Stoma; pouch; Drainable Pouch for collection of stool
• Other Study ID Numbers: CC-0512-13-A740