Ostomy
Conditions
Brief summary
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.
Detailed description
This is a pilot study evaluating the product, 3M™ Cavilon™ Advanced Skin Protectant, for the management of skin around an ostomy, drain and/or fistula. All subjects will receive the product for up to 14 days. The primary site must have red skin with breakdown (i.e. skin erosion and denudation or denudation of skin alone). Secondary sites can have red skin with or without breakdown. Product will be applied twice/week or more frequently if additional applications are needed due to leakage, skin irritation or standard of care. Skin assessments (including photography) will be completed at baseline and at all follow-up visits.
Interventions
Cavilon Advanced Skin Protectant
Sponsors
3M
Solventum US LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Open label no masking required
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Epidermal Skin Loss at the Primary Site Assessed | Baseline, 3 days | 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. |
| Pain Scores at the Primary Site Assessed | Baseline, 3 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cavilon Advanced Skin Protectant Cavion Advanced Skin Protectant was applied to one male subject. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Cavilon Advanced Skin Protectant |
|---|---|
| Age, Customized Age of Subject | 63 years |
| Number of participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: Baseline, 3 days
Population: Pain was rated during and after cleansing at baseline and at Day 3, and during and after product application at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cavilon Advanced Skin Protectant | Pain Scores at the Primary Site Assessed | Baseline Pain During Cleaning | 2 units on a scale |
| Cavilon Advanced Skin Protectant | Pain Scores at the Primary Site Assessed | Baseline Pain After Cleaning | 2 units on a scale |
| Cavilon Advanced Skin Protectant | Pain Scores at the Primary Site Assessed | Baseline Pain During Application | 2 units on a scale |
| Cavilon Advanced Skin Protectant | Pain Scores at the Primary Site Assessed | Baseline Pain After Application | 0 units on a scale |
| Cavilon Advanced Skin Protectant | Pain Scores at the Primary Site Assessed | Day 3 Pain During Cleaning | 0 units on a scale |
| Cavilon Advanced Skin Protectant | Pain Scores at the Primary Site Assessed | Day 3 Pain After Cleaning | 0 units on a scale |
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.
Time frame: Baseline, 3 days
Population: One application of Cavilon Advanced Skin Protectant was applied around the ostomy site. Skin was assessed at baseline and at 3 days after product application.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cavilon Advanced Skin Protectant | Percent of Epidermal Skin Loss at the Primary Site Assessed | Baseline % epidermal loss | 10 Percentage of epidermal skin loss |
| Cavilon Advanced Skin Protectant | Percent of Epidermal Skin Loss at the Primary Site Assessed | Day 3 % epidermal loss | 0 Percentage of epidermal skin loss |