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

Stoma Ileostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202666
• Other study ID #: 201901217A3C601
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Chang Gung Memorial Hospital
• Contact: Wan Hsiang Hu
• Phone: 886-975056227
• Email: gary.hu0805[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Colostomy
• Stoma Ileostomy

Intervention

Device:
• convex 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)

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital,Kaohsiung	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	ConvaTect, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peristomy skin complication rate	peristomy skin complication rate	one month
Secondary	(2) life quality stomy care questionnaire	life quality stomy care questionnaire	one month
Secondary	(3) stomy appliance satisfaction questionnaire	stomy appliance satisfaction questionnaire	one month