The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial

September 14, 2020 updated by: Wan-Hsiang Hu, Chang Gung Memorial Hospital
The incidence of peristomy skin complication ranges from 15% to 65%. It is a serious issue and problem for patients care.The type of skin barrier is associated with peristomy skin complication. How to choose suitable skin barrier is important.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • Chang Gung Memorial Hospital,Kaohsiung
        • Contact:

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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age>20
  • Receive colostomy or ileostomy
  • Agree to join the trial and sign the informed consent form

Exclusion Criteria:

  • Liver cirrhosis
  • Renal insufficiency
  • Severe malnutrition
  • Unstable vital sign
  • Not suitable after evaluation by Principal Investigator

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: not convex skin barrier
no intervention
Experimental: convex skin barrier
intervention
Device: convex skin barrier
Total 300 patients and grouping in 1:1 ratio.(1)peristomy skin complication (30 mins) (2)life quality stomy care (3-5 mins) (3)stomy appliance satisfaction (3-5 mins)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peristomy skin complication rate
Time Frame: one month
peristomy skin complication rate
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(2) life quality stomy care questionnaire
Time Frame: one month
life quality stomy care questionnaire
one month
(3) stomy appliance satisfaction questionnaire
Time Frame: one month
stomy appliance satisfaction questionnaire
one month

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Collaborators

ConvaTect, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 31, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201901217A3C601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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