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

Not Applicable

• Conditions: Stoma Colostomy; Stoma Ileostomy
• Interventions: Device: convex skin barrier

• Registration Number: NCT04202666
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Status Verified: 2020-08
• Study Start: 2020-08-31
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
convex skin barrier	convex skin barrier	intervention

Primary Outcome Measures

Name	Time	Method
peristomy skin complication rate	one month	peristomy skin complication rate

Secondary Outcome Measures

Name	Time	Method
(2) life quality stomy care questionnaire	one month	life quality stomy care questionnaire
(3) stomy appliance satisfaction questionnaire	one month	stomy appliance satisfaction questionnaire

Trial Locations

Locations (1)

Chang Gung Memorial Hospital,Kaohsiung; 🇨🇳 Kaohsiung, Taiwan