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

N/AUnknownNCT04202666

Chang Gung Memorial Hospital300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

300

Conditions

Stoma Colostomy Stoma Ileostomy

Interventions

convex skin barrierDEVICE

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)

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chang Gung Memorial Hospital,Kaohsiung

Kaohsiung City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

peristomy skin complication rate

Time frame: one month

Secondary Outcomes

(2) life quality stomy care questionnaire

life quality stomy care questionnaire

Time frame: one month

(3) stomy appliance satisfaction questionnaire

stomy appliance satisfaction questionnaire

Time frame: one month

Central Contacts

Wan Hsiang Hu

CONTACT

886-975056227 gary.hu0805@gmail.com

Data from ClinicalTrials.gov

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