Clinical trial NCT01935999: One Piece Closed Pouch in Subjects With a Colostomy
Official title: A Single Center Study to Assess the Safety and Performance of a One Piece Closed Pouch in Subjects With a Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colostomy
Keywords: Colostomy
peristomal skin
stoma
pouch
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 10 days - duration of study period
Secondary outcomes:
measure: Performance/Efficacy
timeFrame: 10 days duration of study period
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Independent Nurse Consultants LLC
state: Arizona
Study officials:
affiliation: Unafilliated
name: Ann Popovich-Durnal, RN BSN
role: PRINCIPAL_INVESTIGATOR
References: