Problem statement:
Partial-thickness wounds (erosion/denudation of the epithelial and dermal layers of the
skin) can occur due to prolonged exposure of moisture and irritants. Various sources of
moisture can cause these superficial wounds called moisture-associated skin damage (MASD)
which include wound exudate, bodily fluids from incontinence and effluent from stomas and
fistulas. MASD can present as inflammation with or without erosion and even secondary
infection. Partial-thickness denudation can be extremely painful and detrimental to the
patient. Traditionally a wide array of treatment options is used in clinical practice,
yet there is a lack of robust studies comparing newer technologies with current
practices. 3M™ Cavilon™ Advanced Skin Protectant, launched in 2017, is a newer
cyanoacrylate-based medical device indicated for treatment of partial-thickness skin loss
and is the only cyanoacrylate-based barrier product available on the Belgian market.
Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™
Advanced Skin Protectant in the treatment of partial-thickness wounds caused by moisture
(MASD) compared to usual wound care treatment.
Methodology:
RESEARCH DESIGN: A randomized controlled multicentre clinical trial.
DATA COLLECTION:
Procedure: Demographics and Participant Characteristics: Patient demographics will be
recorded in REDCap eCRFs on study schedule Day 01: gender, age, height, weight,
co-morbidities.
Randomization/Blinding and Participant Numbering: The patients will be allocated 1:1 by
block randomization, using the REDCap Randomization Module, to either Cavilon™ Advanced
Skin Protectant or local hospital partial-thickness wound (MASD) treatment protocol,
yielding one study group. Due to the obvious differences between the comparative hospital
wound care treatment products and the study device, the study nurses cannot be blinded. A
blinded assessor will assess the time to healing and other healing outcomes centrally
based on the photographs of the study area.
Study area: Defined as all partial-thickness, skin damaged areas on the body - due to
exposure to (a) incontinence body fluids, (b) wound exudate, (c) stomal- or fistula
effluent or digestive secretions.
Study duration: 21 days or until complete healing of the moisture associated skin damage
(complete epithelialization).
Hypothesis: 3M™ Cavilon™ Advanced Skin Protectant is more effective in the treatment of
partial-thickness wounds caused by moisture (moisture-associated skin damage) compared to
usual wound care treatment in hospitals.
Skin (MASD) assessment: Daily skin assessment of the study area is to be conducted by the
study nurses. Relevant wound and patient information will be recorded. This information
includes incontinence status, presence of a urinary catheter or faecal management system,
number of absorbent pad or diaper changes, number of cleansing procedures, type of stoma,
number of applications regarding Cavilon Advanced Skin Protectant or usual hospital wound
treatment protocol. Daily photographs will be taken with each daily skin assessment after
removal of all visual product to ensure blinded skin assessment by the central reviewer.
Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of
assessing wound healing. The central reader will perform a blinded skin assessment based
on the provided photographic documentation of the study area.
Pain assessment: The Numeric Rating Scale (NRS) or Crital care Pain Observation Tool
(CPOT) will be used to assess pain daily. Treatment-related pain (pain experienced during
treatment (cleansing and product application)) and wound related pain (pain perception
specifically caused by the MASD lesion) will be assessed.
Nursing time assessment: Time per cleansing and time per treatment application will be
done on days 4 and 7 using a stopwatch.
DATA ANALYSIS:
All quantitative data will be summarized with descriptive statistics.
Inferential analysis: Cox proportional hazards will be used to calculate the primary
efficacy variable. Linear mixed logistic regressions and linear mixed models will be used
to calculate the secondary objectives.
Exploratory analysis: Cox proportional hazards will be used to calculate the primary
efficacy variable. Linear mixed logistic regressions and linear mixed models will be used
to calculate the secondary objectives.
Health economic evaluation: A cost-effectiveness analysis will be performed with an
institutional perspective in a Belgian context. Total cost will be calculated by the sum
of the total product cost and the total cost of nursing time. Costs will be averaged
within each group and compared using a two-signed t-test at an alpha level of 5%. A
cost-effectiveness analysis will be performed by calculating the ICER. The ICER will be
expressed in euros per wound healed per patient.