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Status unknownNCT04202666Updated Sep 16, 2020

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

An interventional study of convex skin barrier in Stoma Colostomy and Stoma Ileostomy, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stoma Colostomy
  • Stoma Ileostomy

Keywords

  • peristomy skin complication
  • convex skin barrier
03

In context

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Liver cirrhosis
  • Renal insufficiency
  • Severe malnutrition
  • Unstable vital sign
  • Not suitable after evaluation by Principal Investigator
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • No intervention
    not convex skin barrier

    no intervention

  • Experimental
    convex skin barrier

    intervention

    Device: convex skin barrier

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)

06

What researchers measure

Primary outcomes

  1. peristomy skin complication rate

    peristomy skin complication rate

    Time frame: one month

Secondary outcomes

  1. (2) life quality stomy care questionnaire

    life quality stomy care questionnaire

    Time frame: one month

  2. (3) stomy appliance satisfaction questionnaire

    stomy appliance satisfaction questionnaire

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
  • Chang Gung Memorial Hospital,Kaohsiung
    Kaohsiung, 833, Taiwan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 17228209 ↗
  • 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. PubMed 17893429 ↗
  • 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. PubMed 21030726 ↗
  • 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. PubMed 22679479 ↗
  • 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. PubMed 28834934 ↗
  • 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. PubMed 28684936 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04202666
Lead sponsor
Chang Gung Memorial Hospital
Collaborators
ConvaTect, Taiwan
Responsible party
Wan-Hsiang Hu (Attending physician, Chang Gung Memorial Hospital) — Principal investigator
First posted
Dec 17, 2019
Start date
Aug 31, 2020
Primary completion
Oct 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Sep 16, 2020

Study contacts

Wan Hsiang Hu
Contact
gary.hu0805@gmail.com
886-975056227

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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