Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin

October 5, 2016 updated by: Hollister Incorporated
This purpose of this study is to look at three commercially available ostomy barriers on peristomal (around the stoma) skin. Repeated barrier application and removal over years causes changes to the skin that the investigators wish to investigate. The primary objective is to measure peel force on normal skin and peel force on peristomal skin, with the intent of determining if differences occur. The study hypotheses is that no differences exist.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single center, non-invasive exploratory study utilizing a sample of convenience. This study compares three commercially available barrier materials on peristomal skin and normal abdominal skin.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • La Grange Park, Illinois, United States, 60526
        • La Grange Center for Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin

Description

Inclusion Criteria:

  • Colostomy, Ileostomy, or Urostomy patients at least 6 months post-surgery
  • Males or females, age 18 to 80 years old at the time of enrollment
  • Body Mass Index (BMI) between 18 and 50
  • Willing to have two approximately 5" x 5" areas of the abdomen trimmed with a surgical clipper -- one in a ring around the stoma, and one on the opposite side
  • Willing to remain within the testing room for the duration of the study
  • Willing to allow a third person in the room as a witness for the duration of the study
  • Able to position oneself onto and off of the examining table without the assistance of the Investigator
  • Willing to refrain from vigorous exercise for the duration of the study
  • Willing to not take any anti-inflammatory medications (except for Tylenol/acetaminophen) starting 48 hours prior to the study and for the duration of the study
  • Willing to bring an extra barrier and replace their barrier worn during the study.
  • Willing to follow the protocol as demonstrated by signing the Informed Consent Form
  • In the opinion of the Investigator or qualified site personnel is qualified to participate

Exclusion Criteria:

  • Clinically significant diseases, which may or may not be confined to the testing site, that may contraindicate participation; including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
  • Use of topical drugs on the application site within 1 month.
  • Use of lotions, creams, powders or oils on the application site in the 24 hours prior to application
  • Pregnancy, lactation or planning a pregnancy as determined by interview only
  • Other medical conditions, for example uncontrolled diabetes, which in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk
  • Participation in any clinical test either using the abdomen as a test site or using systemic therapy within the previous thirty days
  • Damaged skin or other skin conditions in or near test sites which includes sunburn, scars, numerous moles or other disfiguration of the test site
  • Significant adipose tissue at the test site that would preclude adequate adhesion of the study devices
  • Known allergy to any of the test materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control Abdominal Skin
Apply SoftFlex (standard wear commercial skin barrier), FlexWear (standard wear commercial skin barrier), and FlexTend (extended wear commercial skin barrier), material to non-peristomal abdominal skin.
Device: Control Abdominal Skin
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
Other Names:
  • SoftFlex
  • FlexWear
  • FlexTend
Peristomal Abdominal Skin
Apply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin.
Device: Peristomal Abdominal Skin
Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
Other Names:
  • SoftFlex
  • FlexWear
  • FlexTend

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin Barrier Peel Force
Time Frame: 4 hours
Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hollister Incorporated

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Loyola University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Swan, MD, Loyola University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5642-O
  • LUHSC IRB #: 205654091813 (Other Identifier: Hollister Incorporated)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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