Clinical trial NCT06178289: Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skin Damage in Hospitals
Official title: The Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Partial-thickness Wounds Caused by Moisture-associated Skin Damage Compared to Usual Wound Care Treatment in Hospitals: a Multi-centre RCT
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Irritant Dermatitis
Stoma Site Dermatitis
Wound of Skin
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2023-12-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

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 centrally assess the time to healing and other healing outcomes 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).

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 (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). Digital planimetry software (PictZar® version 7.6.1 ss) will be the main mode of assessing wound healing. Therefore, 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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The patient or their legally authorized representative signed informed consent.
* The patient is expected to be in the study for the full duration of the trial.
* The patient has partial thickness wounds caused by moisture (MASD) i.e.,

  * The patient has IAD category 2A or
  * Peri-wound MASD or
  * Peri-stomal MASD.

Exclusion Criteria:

* Patients with a known hypersensitivity or allergy to acrylate or cyanoacrylate.
* The patient requires topical treatment due to a fungal, bacterial or viral infection in the study area.
* Intertriginous dermatitis (most often a fungal infection is present).
* Peri-fistula MASD (would usually require hospitalization).
* The patient has any other local dermatological disease or skin condition interfering with this study.
* Patients participating in another study with a known or implied effect on skin barrier function.
* Patients who are receiving end-of-life care.

Primary outcomes:
measure: Time to complete epithelialization
timeFrame: Day 01 - Day 21
Secondary outcomes:
measure: Proportion of participants with complete epithelialization
timeFrame: Day 07, Day 14, Day 21
measure: Mean change in treatment related pain
timeFrame: Day 01 - Day 21
measure: Mean change in wound pain
timeFrame: Day 01, Day 02, Day 04, Day 07
measure: Change in maceration surface area
timeFrame: Day 07, Day 14, Day 21
measure: Total treatment cost
timeFrame: Day 04, Day 07
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
Study officials:
affiliation: University Ghent
name: Dimitri Beeckman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woo KY, Beeckman D, Chakravarthy D. Management of Moisture-Associated Skin Damage: A Scoping Review. Adv Skin Wound Care. 2017 Nov;30(11):494-501. doi: 10.1097/01.ASW.0000525627.54569.da.
citation: Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, Kennedy-Evans KL, Logan S, Ratliff CR. Moisture-associated skin damage: overview and pathophysiology. J Wound Ostomy Continence Nurs. 2011 May-Jun;38(3):233-41. doi: 10.1097/WON.0b013e318215f798.
citation: Beeckman D, Van den Bussche K, Alves P, Arnold Long MC, Beele H, Ciprandi G, Coyer F, de Groot T, De Meyer D, Deschepper E, Dunk AM, Fourie A, Garcia-Molina P, Gray M, Iblasi A, Jelnes R, Johansen E, Karadag A, Leblanc K, Kis Dadara Z, Meaume S, Pokorna A, Romanelli M, Ruppert S, Schoonhoven L, Smet S, Smith C, Steininger A, Stockmayr M, Van Damme N, Voegeli D, Van Hecke A, Verhaeghe S, Woo K, Kottner J. Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries. Br J Dermatol. 2018 Jun;178(6):1331-1340. doi: 10.1111/bjd.16327. Epub 2018 Apr 19.