Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04202666
Other study ID # 201901217A3C601
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT06269276 - Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
Not yet recruiting NCT05076669 - Quality of Life Impact After Enhanced Follow-up of Ostomy Patients N/A
Terminated NCT03016195 - Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies N/A
Recruiting NCT04763863 - The Nordic Consensus Study
Completed NCT05970458 - Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden
Completed NCT05601024 - The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma N/A
Completed NCT05135754 - Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation N/A
Completed NCT01994902 - Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy N/A
Recruiting NCT03424447 - Stimulation of the Efferent Loop Before Loop Ileostomy Closure Phase 2
Recruiting NCT04984161 - The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses N/A
Completed NCT05531331 - The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma N/A
Active, not recruiting NCT06458699 - Management Of Stoma In Patients Younger Than 3 Months Old
Recruiting NCT04374890 - Evaluation of a New Supporting Ostomy Product N/A
Not yet recruiting NCT06391398 - The Impact of Education Using a Stoma Care Training Belt N/A
Recruiting NCT04709445 - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses N/A
Completed NCT04744792 - QoL of Colorectal Cancer Patients and Spouses
Completed NCT03971513 - Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study N/A
Completed NCT03200444 - Evaluation of the Peel Force of New Adhesives From the Skin N/A
Completed NCT03619226 - Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture N/A
Completed NCT06237686 - Clinical Investigation Exploring Two Ostomy Product Prototypes N/A