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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04202666
Enrollment
300
Registered
2019-12-17
Start date
2020-08-31
Completion date
2021-12-31
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stoma Colostomy, Stoma Ileostomy

Keywords

peristomy skin complication, convex skin barrier

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.

Interventions

DEVICEconvex 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)

Sponsors

ConvaTect, Taiwan
CollaboratorUNKNOWN
Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
peristomy skin complication rateone monthperistomy skin complication rate

Secondary

MeasureTime frameDescription
(2) life quality stomy care questionnaireone monthlife quality stomy care questionnaire
(3) stomy appliance satisfaction questionnaireone monthstomy appliance satisfaction questionnaire

Countries

Taiwan

Contacts

Primary ContactWan Hsiang Hu
gary.hu0805@gmail.com886-975056227

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026