Stoma ColostomyNCT04202666
The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial
A study testing convex skin barrier in people with Stoma Colostomy and Stoma Ileostomy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- convex skin barrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>20
- Receive colostomy or ileostomy
- Agree to join the trial and sign the informed consent form
Who cannot join
- Liver cirrhosis
- Renal insufficiency
- Severe malnutrition
- Unstable vital sign
- Not suitable after evaluation by Principal Investigator
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital,Kaohsiung
Kaohsiung City, 833
Wan Hsiang Hu, +886-7-7317123 ext. 8008, gary.hu0805@gmail.com
About this study
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.
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Being tested
- convex skin barrier
- Keywords
- peristomy skin complication, convex skin barrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| not convex skin barrier | No intervention | no intervention |
| convex skin barrier | Experimental | intervention Receives: Device: convex skin barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
peristomy skin complication rate
peristomy skin complication rate
Measured: one month
Secondary outcomes (2)
(2) life quality stomy care questionnaire
life quality stomy care questionnaire
Measured: one month
(3) stomy appliance satisfaction questionnaire
stomy appliance satisfaction questionnaire
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start31 Aug 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTect, Taiwan
- Responsible party
- Principal investigator, Wan-Hsiang Hu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202666
- Sponsor's protocol ID
- 201901217A3C601
- Status last verified
- Aug 2020
- First submitted
- 28 Nov 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 17228209Bosio 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 17893429Beitz 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 21030726Meisner 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 22679479Hoeflok 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 28834934Steinhagen 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Convex Skin Barrier in Prevention of Peristomy Skin Complication-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04202666
- Acronym / sponsor ID
- 201901217A3C601
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Keywords
- peristomy skin complication, convex skin barrier
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- ConvaTect, Taiwan
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| not convex skin barrier | No intervention | –no intervention |
| convex skin barrier | Experimental | Device: convex skin barrierintervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>20
- Receive colostomy or ileostomy
- Agree to join the trial and sign the informed consent form
Key exclusion criteria (5 listed)
- Liver cirrhosis
- Renal insufficiency
- Severe malnutrition
- Unstable vital sign
- Not suitable after evaluation by Principal Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| convex skin barrierTotal 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) | Device | convex skin barrier |
Primary outcome
peristomy skin complication rate
Time frame: one month
peristomy skin complication rate
2 secondary outcomes
(2) life quality stomy care questionnaire
Time frame: one month
(3) stomy appliance satisfaction questionnaire
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 17228209Colwell 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.
- Background: PubMed 17893429Bosio 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.
- Background: PubMed 21030726Beitz 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.
- Background: PubMed 22679479Meisner 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.
- Background: PubMed 28834934Hoeflok 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.
- Background: PubMed 28684936Steinhagen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing convex skin barrier in people with Stoma Colostomy and Stoma Ileostomy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan Hsiang Hu (886-975056227, gary.hu0805@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peristomy skin complication rate (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202666, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.