The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial
NCT ID: NCT04202666
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
300 participants
INTERVENTIONAL
2020-08-31
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Evaluation of the Peristomal Skin Condition in Ostomates
NCT01526967
User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
NCT02499588
Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.
NCT07316530
Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Reverse Stoma
NCT02053948
A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
NCT01782196
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
not convex skin barrier
no intervention
No interventions assigned to this group
convex skin barrier
intervention
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Receive colostomy or ileostomy
* Agree to join the trial and sign the informed consent form
Exclusion Criteria
* Renal insufficiency
* Severe malnutrition
* Unstable vital sign
* Not suitable after evaluation by Principal Investigator
20 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ConvaTect, Taiwan
UNKNOWN
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wan-Hsiang Hu
Attending physician
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chang Gung Memorial Hospital,Kaohsiung
Kaohsiung City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201901217A3C601
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.