Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03619226
Other study ID # CP284_1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2, 2018
Est. completion date July 4, 2018

Study information

Verified date August 2018
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date July 4, 2018
Est. primary completion date July 4, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Have given written informed consent

2. Be at least 18 years of age and have full legal capacity

3. Have intact skin on the area used in the evaluation

4. Have an abdominal area accessible for application of test product (assessed by investigator)

5. Negative pregnancy test for fertile women

6. Signed document claiming use of safe contraceptives for fertile women

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy

2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.

3. Are pregnant or breastfeeding

4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)

5. Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
test patch
the test patch consists of an adhesive patch

Locations

Country Name City State
Denmark Coloplast A/S Humlebæk

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resistance (Moisture in the adhesive) moisture in adhesive is measured using a measurement probe 3 days
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 NCT06237686 - Clinical Investigation Exploring Two Ostomy Product Prototypes N/A
Completed NCT03044262 - Evaluation of the Influence of New Adhesives of Output on Skin N/A