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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1
Cavilon Advanced Skin Protectant
Eastern Regional Medical Center, Inc.
Philadelphia, Pennsylvania, United States
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
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
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