Clinical trial NCT03057132: Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ostomy
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2017-02-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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?

Primary outcomes:
measure: Percent of Epidermal Skin Loss at the Primary Site Assessed
timeFrame: Baseline, 3 days
measure: Pain Scores at the Primary Site Assessed
timeFrame: Baseline, 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center, Inc.
state: Pennsylvania
Study officials:
affiliation: 3M
name: Matthew Cooper, MD
role: STUDY_DIRECTOR
References: