NCT04202666

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 16, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

November 28, 2019

Last Update Submit

September 14, 2020

Conditions

Stoma ColostomyStoma Ileostomy

Keywords

peristomy skin complicationconvex skin barrier

Outcome Measures

Primary Outcomes (1)

  • peristomy skin complication rate

    peristomy skin complication rate

    one month

Secondary Outcomes (2)

  • (2) life quality stomy care questionnaire

    one month

  • (3) stomy appliance satisfaction questionnaire

    one month

Study Arms (2)

not convex skin barrier

NO INTERVENTION

no intervention

convex skin barrier

EXPERIMENTAL

intervention

Device: convex skin barrier

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)

convex skin barrier

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital,Kaohsiung

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (6)

  • Colwell JC, Beitz J. Survey of wound, ostomy and continence (WOC) nurse clinicians on stomal and peristomal complications: a content validation study. J Wound Ostomy Continence Nurs. 2007 Jan-Feb;34(1):57-69. doi: 10.1097/00152192-200701000-00010.

    PMID: 17228209BACKGROUND

  • Bosio G, Pisani F, Lucibello L, Fonti A, Scrocca A, Morandell C, Anselmi L, Antonini M, Militello G, Mastronicola D, Gasperini S. A proposal for classifying peristomal skin disorders: results of a multicenter observational study. Ostomy Wound Manage. 2007 Sep;53(9):38-43.

    PMID: 17893429BACKGROUND

  • Beitz J, Gerlach M, Ginsburg P, Ho M, McCann E, Schafer V, Scott V, Stallings B, Turnbull G. Content validation of a standardized algorithm for ostomy care. Ostomy Wound Manage. 2010 Oct;56(10):22-38.

    PMID: 21030726BACKGROUND

  • Meisner S, Lehur PA, Moran B, Martins L, Jemec GB. Peristomal skin complications are common, expensive, and difficult to manage: a population based cost modeling study. PLoS One. 2012;7(5):e37813. doi: 10.1371/journal.pone.0037813. Epub 2012 May 24.

    PMID: 22679479BACKGROUND

  • Hoeflok J, Purnell P. Understanding the role of convex skin barriers in ostomy care. Nursing. 2017 Sep;47(9):51-56. doi: 10.1097/01.NURSE.0000516224.24273.88. No abstract available.

    PMID: 28834934BACKGROUND

  • Steinhagen E, Colwell J, Cannon LM. Intestinal Stomas-Postoperative Stoma Care and Peristomal Skin Complications. Clin Colon Rectal Surg. 2017 Jul;30(3):184-192. doi: 10.1055/s-0037-1598159. Epub 2017 May 22.

    PMID: 28684936BACKGROUND

Central Study Contacts

Wan Hsiang Hu

CONTACT

886-975056227gary.hu0805@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 17, 2019

Study Start

August 31, 2020

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

September 16, 2020

Record last verified: 2020-08

Locations

TW(1)