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

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ClinicalTrials.gov Identifier: NCT02003404
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : October 19, 2015
Last Update Posted : November 11, 2016
Sponsor:
Collaborator:
Loyola University
Information provided by (Responsible Party):
Hollister Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment
Dermatologic Complications Device: Control Abdominal Skin Device: Peristomal Abdominal Skin

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.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
Study Start Date : November 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003404


Locations
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United States, Illinois
La Grange Center for Health
La Grange Park, Illinois, United States, 60526
Sponsors and Collaborators
Hollister Incorporated
Loyola University
Investigators
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Principal Investigator: James Swan, MD Loyola University
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Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT02003404    
Other Study ID Numbers: 5642-O
LUHSC IRB #: 205654091813 ( Other Identifier: Hollister Incorporated )
First Posted: December 6, 2013    Key Record Dates
Results First Posted: October 19, 2015
Last Update Posted: November 11, 2016
Last Verified: October 2016
Keywords provided by Hollister Incorporated:
ostomy appliance