Ostomy Clinical Trial
Official title:
A Pilot Study Evaluating the Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
Verified date | May 2019 |
Source | 3M |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site or fistula.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Is the subject 18 years of age or older? 2. Does the subject have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone) at the primary site of an ostomy, drain and/or fistula? 3. Is the subject willing to have photographs taken of their skin and permit use of photographs in potential publication? 4. Is the subject willing to release rights to 3M for the use of the photos? 5. Is there a reasonable expectation that the subject will be in the hospital or available for follow-up visits during the 14 day study period? 6. Has the subject signed an Institutional Review Board-approved informed consent/assent document and authorized the use and disclosure of protected health information? Exclusion Criteria: 1. If female, is the subject pregnant or breast feeding or has she given birth within the 3 weeks preceding the screening visit? 2. Does the subject have a known allergy to acrylates or cyanoacrylates? 3. Does the subject have a preexisting skin disease on the areas affected that may make skin assessments for this study difficult? 4. Does the skin area affected require treatment with a concomitant medication or product? 5. Has the subject received antifungal powders in the area affected within 24 hours prior to enrollment? 6. Has the subject received cyanoacrylate based skin protectant (such as Marathon) within 72 hours prior to enrollment? 7. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study? 8. Has the subject been enrolled in any investigational study where product was applied to proposed study sites within 30 days of the screening visit? |
Country | Name | City | State |
---|---|---|---|
United States | Eastern Regional Medical Center, Inc. | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
3M |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Epidermal Skin Loss at the Primary Site Assessed | The primary endpoint is the improvement of denuded skin (defined as clinical improvement from the baseline skin assessment) of the primary site of interest (ostomy). The primary response was the percent of skin at primary site of interest with epidermal loss observed at baseline and at 3 days post product application. |
Baseline, 3 days | |
Primary | Pain Scores at the Primary Site Assessed | Improvement in pain from baseline to the end of the study. The Wong-Baker FACES® Pain Visual Analog Pain Scale was used to assess pain at each time point. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower score is better. | Baseline, 3 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06065995 -
StoMakker Mobile Application
|
N/A | |
Completed |
NCT01691729 -
Comparison Study of 3 Ostomy Products
|
N/A | |
Active, not recruiting |
NCT00391508 -
Skin Problems in Ostomy Patients: An Epidemiological Study
|
N/A | |
Recruiting |
NCT04943822 -
The Effectiveness of APP Intervention on Home Self-care Ability and Quality of Life of Patients With Intestinal Stoma
|
N/A | |
Recruiting |
NCT03715179 -
Observational Study of Ostomy Consumers
|
||
Recruiting |
NCT02319434 -
Ostom-i Alert Sensor Quality of Life Validation
|
||
Terminated |
NCT02036268 -
Different Levels of Patient Education for Care of Ostomy Site
|
N/A | |
Not yet recruiting |
NCT06310070 -
3D Printed Personalized Ostomy Appliance
|
N/A | |
Completed |
NCT02401412 -
The Advocate Study
|
N/A | |
Active, not recruiting |
NCT05745909 -
Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy
|
N/A | |
Completed |
NCT02889536 -
Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences
|
N/A | |
Recruiting |
NCT05796544 -
Effectiveness of Remote Self-care Education for Ostomy Patients
|
N/A | |
Completed |
NCT05573256 -
Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life
|
N/A | |
Terminated |
NCT02472639 -
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
|
N/A | |
Recruiting |
NCT04326335 -
Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
|
N/A | |
Unknown status |
NCT01526967 -
Observational Evaluation of the Peristomal Skin Condition in Ostomates
|
N/A | |
Completed |
NCT04635215 -
Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology
|
||
Recruiting |
NCT06213441 -
Improving the Quality of Life and Self-sufficiency of Individuals With Stoma: Pecha Kucha Training Via Smartphone
|
N/A | |
Completed |
NCT01261988 -
Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
|
Phase 1 | |
Completed |
NCT04561674 -
The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy
|
N/A |