One Piece Closed Pouch in Subjects With a Colostomy

A Single Center Study to Assess the Safety and Performance of a One Piece Closed Pouch in Subjects With a Colostomy

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

Study Overview

• Status: Completed
• Conditions: Colostomy
• Intervention / Treatment: Device: One piece closed pouch

Detailed Description

Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85742
      • Independent Nurse Consultants 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:

• 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 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 closed pouch	Device: One piece closed pouch; A one piece closed pouch for the collection of stool from a colostomy stoma; Other Names: Enhanced one piece closed pouch

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 29, 2013
• First Submitted That Met QC Criteria: September 2, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Estimate): September 6, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Colostomy; pouch; stoma; peristomal skin
• Other Study ID Numbers: CC-0512-13-A741