Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178289
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-11-30
Brief Title:
Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skin Damage in Hospitals
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISR-CASP-MASD
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
RandomizationBlinding and Participant Numbering The patients will be allocated 11 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 761 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 Wong-Baker FACES Pain Rating Scale 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
Methodology
RESEARCH DESIGN A randomized controlled multicentre clinical trial
DATA COLLECTION
RandomizationBlinding and Participant Numbering The patients will be allocated 11 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 761 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 Wong-Baker FACES Pain Rating Scale 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 erosiondenudation 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
RandomizationBlinding and Participant Numbering The patients will be allocated 11 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 761 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
Partial-thickness wounds erosiondenudation 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
RandomizationBlinding and Participant Numbering The patients will be allocated 11 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 761 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None