Back to resultsClinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Primary Purpose
Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bordered Five-Layer Foam Dressing
Hydropolymer Foam Dressing
Hydrocellular Multi-Layer Foam Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Wound focused on measuring Chronic wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Wound dressing
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
- Signed informed consent.
- Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
- Study subject must be available and able to visit the clinic weekly for the full 4-week period.
Exclusion Criteria:
- Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
- Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
- Subject has any evidence of peripheral arterial disease (PAD).
- Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
- Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
- Pregnancy or lactation at time of study participation.
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
- Present history of alcohol or drug abuse.
- Known allergy/hypersensitivity to any of the components of the dressing.
- Subject not suitable for the investigation according to the investigator's judgment.
Sites / Locations
- Center for Clinical Research, Inc.
- Center for Clinical Trials, Inc.
- Vascular and Wound Care Center
- SerenaGroup Research Foundation
- SerenaGroup
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Five-layer vs Hydropolymer
Hydropolymer vs Five-layer
Five-layer vs Hydrocellular
Hydrocellular vs Five-layer
Arm Description
Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks.
Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks.
Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
Outcomes
Primary Outcome Measures
% of Participants With Equal or Better Rate of Dressing Durability
Dressing strike-through determined @ Wk1 Day 3&7, and Wk3 Day 17&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset.
Contributing factors to strike-through:
Saturation of dressing pad:
Inappropriate dressing type
Inappropriate dressing change freq. (i.e. more frequent changes required)
Change in wound condition (e.g. increase in exudate amt)
Dislodgement of dressing:
Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation)
Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility)
Patient interference w/ dressing
Dressing design deficiency:
Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission)
Insufficient adhesion
Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations)
% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
Intact dressing after 7 days wear time, assessed @ Wk1 Day7 & Wk3 Day21 only. 1st week of dressing wear (Wks 1 & 3) is critical for start of wound healing.
Contributing factors to strike-through:
Saturation of dressing pad:
Inappropriate dressing type
Inappropriate dressing change freq. (i.e. more frequent changes required)
Change in wound condition (e.g. increase in exudate amt)
Dislodgement of dressing:
Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation)
Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility)
Patient interference w/ dressing
Dressing design deficiency:
Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission)
Insufficient adhesion
Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations)
Secondary Outcome Measures
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
% of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings
Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through.
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation
Wound granulation was measured by visual assessment and photodigital planimetry. Wound granulation were grouped into 6 categories: None, <25%, 25-49%, 50-74%, 75-99%, 100%.
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both)
Non-viable tissue was determined by visual assessment and photodigital planimetry. Non-viable tissues were grouped into 5 categories: None, <25%, 25-49%, 50-74%, 75-100%.
Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire
The SF-12 health survey consists of 12 questions that yield an eight-scale profile of functional health and well-being, and 2 component summary measures of physical and mental health. SF-12 scores range from 0 to 100 with lower scores indicate lower levels of health.
SF-12 questionnaire was administered at Screening/Baseline, Day 14, and Day 28 visits, and scored by a 3rd party vendor.
Results are mean differences between five-layer vs the comparator dressing and presented for each of the 8 health domains, and 2 component summary measures.
Negative scores indicate lower SF-12 scores (indicating lower levels of health) for the five-layer treatment group; positive scores indicate higher SF-12 scores for the five-layer group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03662997
Brief Title
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Official Title
A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
Detailed Description
The study will be conducted in an outpatient setting of an academic clinical center over a total period of four weeks (28 days, -1/+2).
The aim of this RCT is to evaluate and compare three different foam dressings in the local management of chronic wounds (i.e. venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)) in an outpatient setting. A bordered, five-layer, flexible foam dressing with soft silicone adhesive technology will be evaluated versus a hydropolymer, adhesive foam island dressing and a multi-layered, hydrocellular foam dressing with silicone adhesive, within three focus areas; efficacy and safety of the dressings, participant-centric outcomes and health economic evaluation.
Note: The terms used within the body of this report and results, in both the Primary and Secondary Outcomes, are defined as follows:
Period 1: Weeks 1 and 2 of study follow-up visits. Period 2: Weeks 3 and 4 of study follow-up visits. Week 1: Designates data captured only on visit days 7 and 21. Week 2: Designates data captured only on visit days 14 and 28. During Week 1: Designates data captured on visit days 3, 7, 17 and 21. During Week 2: Designates data captured on visit days 10, 14, 24 and 28. Day 3 of Week 1 from tables: inclusive of data captured on Visit Days 3 and 17. Day 3 of Week 2 from tables: inclusive of data captured on Visit Days 10 and 24.
Day 7 of Week 1 from tables: inclusive of data captured on Visit Days 7 and 21. Day 7 of Week 2 from tables: inclusive of data captured on Visit Days 14 and 28.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
Keywords
Chronic wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Wound dressing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a prospective RCT using a crossover design to evaluate safety and efficacy. The study will be conducted in an outpatient setting of an academic clinical center. There will be two participant groups: those with VLU and those with DFU. Approximately 50% of the participants will be in the VLU group and 50% of the participants in the DFU group. Treatment sequence will be randomized so that a fair distribution is achieved. Each participant will receive a 2-week treatment with one of the three dressings followed by a 2-week treatment period with a second dressing (i.e. each participant will receive treatment with two different dressings, either the Bordered Five-Layer Foam Dressing and the Hydropolymer Foam Dressing, or the Bordered Five-Layer Foam Dressing and the Hydrocellular Multi-Layer Foam Dressing) using a cross-over (repeated measures) design, with a total of four study arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Five-layer vs Hydropolymer
Arm Type
Active Comparator
Arm Description
Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks.
Arm Title
Hydropolymer vs Five-layer
Arm Type
Active Comparator
Arm Description
Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
Arm Title
Five-layer vs Hydrocellular
Arm Type
Active Comparator
Arm Description
Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks.
Arm Title
Hydrocellular vs Five-layer
Arm Type
Active Comparator
Arm Description
Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
Intervention Type
Device
Intervention Name(s)
Bordered Five-Layer Foam Dressing
Other Intervention Name(s)
Five-layer
Intervention Description
Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology
Intervention Type
Device
Intervention Name(s)
Hydropolymer Foam Dressing
Other Intervention Name(s)
Hydropolymer
Intervention Description
Hydropolymer, adhesive foam island dressing
Intervention Type
Device
Intervention Name(s)
Hydrocellular Multi-Layer Foam Dressing
Other Intervention Name(s)
Hydrocellular
Intervention Description
Multi-layered, hydrocellular foam dressing with silicone adhesive
Primary Outcome Measure Information:
Title
% of Participants With Equal or Better Rate of Dressing Durability
Description
Dressing strike-through determined @ Wk1 Day 3&7, and Wk3 Day 17&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset.
Contributing factors to strike-through:
Saturation of dressing pad:
Inappropriate dressing type
Inappropriate dressing change freq. (i.e. more frequent changes required)
Change in wound condition (e.g. increase in exudate amt)
Dislodgement of dressing:
Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation)
Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility)
Patient interference w/ dressing
Dressing design deficiency:
Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission)
Insufficient adhesion
Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations)
Time Frame
4 weeks
Title
% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
Description
Intact dressing after 7 days wear time, assessed @ Wk1 Day7 & Wk3 Day21 only. 1st week of dressing wear (Wks 1 & 3) is critical for start of wound healing.
Contributing factors to strike-through:
Saturation of dressing pad:
Inappropriate dressing type
Inappropriate dressing change freq. (i.e. more frequent changes required)
Change in wound condition (e.g. increase in exudate amt)
Dislodgement of dressing:
Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation)
Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility)
Patient interference w/ dressing
Dressing design deficiency:
Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission)
Insufficient adhesion
Insufficient conformability (i.e. ability to conform to body contours & challenging anatomical wound locations)
Time Frame
Weeks 1 and 3
Secondary Outcome Measure Information:
Title
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer
Description
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
Time Frame
4 weeks
Title
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer
Description
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
Time Frame
4 weeks
Title
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer
Description
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
Time Frame
4 weeks
Title
% of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings
Description
Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through.
Time Frame
4 weeks
Title
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation
Description
Wound granulation was measured by visual assessment and photodigital planimetry. Wound granulation were grouped into 6 categories: None, <25%, 25-49%, 50-74%, 75-99%, 100%.
Time Frame
4 weeks
Title
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both)
Description
Non-viable tissue was determined by visual assessment and photodigital planimetry. Non-viable tissues were grouped into 5 categories: None, <25%, 25-49%, 50-74%, 75-100%.
Time Frame
4 weeks
Title
Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire
Description
The SF-12 health survey consists of 12 questions that yield an eight-scale profile of functional health and well-being, and 2 component summary measures of physical and mental health. SF-12 scores range from 0 to 100 with lower scores indicate lower levels of health.
SF-12 questionnaire was administered at Screening/Baseline, Day 14, and Day 28 visits, and scored by a 3rd party vendor.
Results are mean differences between five-layer vs the comparator dressing and presented for each of the 8 health domains, and 2 component summary measures.
Negative scores indicate lower SF-12 scores (indicating lower levels of health) for the five-layer treatment group; positive scores indicate higher SF-12 scores for the five-layer group.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
Signed informed consent.
Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
Study subject must be available and able to visit the clinic weekly for the full 4-week period.
Exclusion Criteria:
Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
Subject has any evidence of peripheral arterial disease (PAD).
Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
Pregnancy or lactation at time of study participation.
Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
Present history of alcohol or drug abuse.
Known allergy/hypersensitivity to any of the components of the dressing.
Subject not suitable for the investigation according to the investigator's judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Alvarez
Organizational Affiliation
Vascular and Wound Care Center, University Hospital, Newark, NJ, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Research, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Center for Clinical Trials, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Vascular and Wound Care Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
SerenaGroup Research Foundation
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States
Facility Name
SerenaGroup
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
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