NCT02401412

Brief Summary

Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 11, 2018

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

March 24, 2015

Results QC Date

April 5, 2018

Last Update Submit

June 13, 2018

Conditions

Ostomy

Outcome Measures

Primary Outcomes (1)

  • Stoma Related Cost of Care

    12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.

    12 weeks

Secondary Outcomes (1)

  • Peristomal Skin Complication Rate

    8 weeks

Study Arms (2)

Test Ostomy Barrier

OTHER

The test product is a new Hollister ostomy barrier.

Device: Test Ostomy Barrier

Control Ostomy Barrier

OTHER

The control product is a currently marketed Hollister ostomy barrier.

Device: Control Ostomy Barrier

Interventions

Test Ostomy BarrierDEVICE
Test Ostomy Barrier
Control Ostomy BarrierDEVICE
Control Ostomy Barrier

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ostomy patients who:
  • Have healthy peristomal skin
  • Are within 12 weeks post op

You may not qualify if:

  • Ostomy patients who:
  • Have a fistula, wound, lesion or suspected infection in the peristomal area
  • Are in-patient in healthcare facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Stoia Consultants

Riverside, California, 92508, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Winter Haven Hospital

Winter Haven, Florida, 33881, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Indiana Health Ball Memorial University

Muncie, Indiana, 47303, United States

Location

Restored Images

Kansas City, Missouri, 64119, United States

Location

Klein's Orthopedic & Medical Supply

Cuyahoga Falls, Ohio, 44223, United States

Location

St. Elizabeth Hospital

Youngstown, Ohio, 44504, United States

Location

Lakeside Medicine Center

Kelowna, British Columbia, V1M 3C2, Canada

Location

Pharmasave

Nanaimo, British Columbia, V9S 5W4, Canada

Location

Ostomy Care Centre

New Westminster, British Columbia, V3M 2T5, Canada

Location

Rouge Valley Health System

Toronto, Ontario, M1E 489, Canada

Location

Results Point of Contact

Title
Stacy Haddad, Global Clinical Affairs Director
Organization
Hollister Incorporated
stacy.haddad@hollister.com
847-680-2837

Study Officials

  • Mark Kalifa

    Hollister Incorporated

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

March 16, 2015

Primary Completion

January 20, 2017

Study Completion

February 3, 2017

Last Updated

July 11, 2018

Results First Posted

July 11, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

Locations

CA(4)US(8)