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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Stoma Colostomy; Stoma Ileostomy

Treatments: Device: convex skin barrier

Study type: Interventional

Funder types: Other

Identifiers

NCT04202666

201901217A3C601

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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300 participants in 2 patient groups

not convex skin barrier

No Intervention group

Description:

no intervention

convex skin barrier

Experimental group

Description:

intervention

Treatment:

Device: convex skin barrier