Chronic Wound, Diabetic Foot Ulcer, Venous Leg Ulcer
Conditions
Keywords
Chronic wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Wound dressing
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.
Interventions
DEVICEBordered Five-Layer Foam Dressing
Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology
DEVICEHydropolymer Foam Dressing
Hydropolymer, adhesive foam island dressing
DEVICEHydrocellular Multi-Layer Foam Dressing
Multi-layered, hydrocellular foam dressing with silicone adhesive
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU). 2. Signed informed consent. 3. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear. 4. Study subject must be available and able to visit the clinic weekly for the full 4-week period.
Exclusion criteria
1. Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP). 2. Presence of local wound infection as determined by study doctor based on clinical signs and symptoms. 3. Subject has any evidence of peripheral arterial disease (PAD). 4. Subject diagnosed with malignancy other than cutaneous basal cell carcinoma. 5. 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. 6. Pregnancy or lactation at time of study participation. 7. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization. 8. Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study. 9. Present history of alcohol or drug abuse. 10. Known allergy/hypersensitivity to any of the components of the dressing. 11. Subject not suitable for the investigation according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Participants With Equal or Better Rate of Dressing Durability | 4 weeks | 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 | Weeks 1 and 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | 4 weeks | 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 | 4 weeks | 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 on Local Wound and Skin Pain Before Dressing Removal With Five-layer | 4 weeks | 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 When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | 4 weeks | 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 | 4 weeks | 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. |
| % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | 4 weeks | 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 on Local Wound and Skin Pain at Removal With Five-layer | 4 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
40 participants were randomized and received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Hydropolymer vs Five-layer Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks | 11 |
| Five-layer vs Hydropolymer Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks | 8 |
| Hydrocellular vs Five-layer Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks | 11 |
| Five-layer vs Hydrocellular Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks | 8 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Hydrocellular vs Five-layer | Five-layer vs Hydrocellular | Total | Hydropolymer vs Five-layer | Five-layer vs Hydropolymer |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 12 Participants | 5 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 26 Participants | 6 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — | — |
| Region of Enrollment United States | 11 participants | 8 participants | 38 participants | 11 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 12 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 26 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 11 | 4 / 9 | 0 / 11 | 1 / 9 |
| other Total, other adverse events | 1 / 11 | 4 / 9 | 0 / 11 | 1 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 | 0 / 11 | 0 / 9 |
Outcome results
Primary
% 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)
Time frame: 4 weeks
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare # of incidences of strike-through when participants received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Rate of Dressing Durability | Weeks 1 & 3 Five-layer equal or better | 100.0 %participants |
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Rate of Dressing Durability | Weeks 2 & 4 Five-layer equal or better | 69.2 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Rate of Dressing Durability | Weeks 2 & 4 Five-layer equal or better | 73.3 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Rate of Dressing Durability | Weeks 1 & 3 Five-layer equal or better | 94.1 %participants |
p-value: 0.046Chi-squared
p-value: 0.56Chi-squared
p-value: 0.01Chi-squared
p-value: 0.25Chi-squared
Primary
% 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)
Time frame: Weeks 1 and 3
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare # of incidences of strike-through when participants received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 | Five-layer | 43.8 %participants |
| Five-layer vs Hydropolymer | % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 | Comparator | 12.5 %participants |
| Five-layer vs Hydrocellular | % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 | Five-layer | 35.3 %participants |
| Five-layer vs Hydrocellular | % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 | Comparator | 5.6 %participants |
p-value: 0.046Chi-squared, Corrected
p-value: 0.01Chi-squared, Corrected
Secondary
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.
Time frame: 4 weeks
Population: ITT analysis set. Means and standard deviations represent participants' responses from follow-up visits aggregated. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting \& analysis in order to compare health-related quality-of-life when using each type of dressing. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Physical Functioning | -0.896 score on a scale | Standard Deviation 9.386 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Physical Component | -0.545 score on a scale | Standard Deviation 7.777 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Role Physical | 1.99 score on a scale | Standard Deviation 10.47 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Bodily Pain | -6.57 score on a scale | Standard Deviation 9.8 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in General Health | -0.449 score on a scale | Standard Deviation 5.788 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Role Emotional | -6.26 score on a scale | Standard Deviation 12.68 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Social Functioning | -7.12 score on a scale | Standard Deviation 15.19 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Vitality | -0.767 score on a scale | Standard Deviation 14.391 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Mental Health | -2.70 score on a scale | Standard Deviation 7.7 |
| Five-layer vs Hydropolymer | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Mental Component | -4.61 score on a scale | Standard Deviation 9.35 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Vitality | 2.63 score on a scale | Standard Deviation 12.72 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in General Health | 3.47 score on a scale | Standard Deviation 9.89 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Physical Component | 1.00 score on a scale | Standard Deviation 10.06 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Social Functioning | -0.661 score on a scale | Standard Deviation 18.685 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Mental Health | 0.395 score on a scale | Standard Deviation 9.036 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Physical Functioning | -3.13 score on a scale | Standard Deviation 13.84 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Mental Component | 0.078 score on a scale | Standard Deviation 9.964 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Role Physical | 0.001 score on a scale | Standard Deviation 11.461 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Role Emotional | -2.61 score on a scale | Standard Deviation 5.35 |
| Five-layer vs Hydrocellular | Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire | Change in Bodily Pain | 5.11 score on a scale | Standard Deviation 14.31 |
Secondary
% 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.
Time frame: 4 weeks
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting \& analysis in order to compare level of local wound and skin pain among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer | Week 1&3 Fiver-layer equal or better | 69.3 %participants |
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer | Week 2&4 Five-layer equal or better | 100.0 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer | Week 1&3 Fiver-layer equal or better | 87.6 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer | Week 2&4 Five-layer equal or better | 58.3 %participants |
Secondary
% 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.
Time frame: 4 weeks
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare level of local wound and skin pain among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer | Week 1&3 Five-layer equal or better | 92.3 %participants |
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer | Week 2&4 Five-layer equal or better | 100.0 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer | Week 1&3 Five-layer equal or better | 75.1 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer | Week 2&4 Five-layer equal or better | 83.4 %participants |
Secondary
% 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.
Time frame: 4 weeks
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting \& analysis in order to compare level of local wound and skin pain among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | Week 1&3 Five-layer equal or better | 77.0 %participants |
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | Week 2&4 Five-layer equal or better | 90.9 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | Week 1&3 Five-layer equal or better | 81.3 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer | Week 2&4 Five-layer equal or better | 58.4 %participants |
Secondary
% 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.
Time frame: 4 weeks
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting \& analysis in order to compare level of saturation in the dressings among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings | Week 1&3 Five-layer equal or better | 100.0 %participants |
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings | Week 2&4 Five-layer equal or better | 84.6 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings | Week 1&3 Five-layer equal or better | 70.6 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings | Week 2&4 Five-layer equal or better | 73.3 %participants |
Secondary
% 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%.
Time frame: 4 weeks
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting \& analysis in order to compare level of wound granulation among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | Week 1&3 Five-layer equal or better | 92.3 %participants |
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | Week 2&4 Five-layer equal or better | 81.8 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | Week 1&3 Five-layer equal or better | 93.8 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation | Week 2&4 Five-layer equal or better | 66.7 %participants |
Secondary
% 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%.
Time frame: 4 weeks
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting \& analysis to compare the amount of non-viable tissue in the wound among participants who received one dressing or the other first for the 4 week treatment phase. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | Week 1&3 Five-layer equal or better | 100.0 %participants |
| Five-layer vs Hydropolymer | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | Week 2&4 Five-layer equal or better | 90.9 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | Week 2&4 Five-layer equal or better | 91.6 %participants |
| Five-layer vs Hydrocellular | % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) | Week 1&3 Five-layer equal or better | 93.8 %participants |
Post Hoc
% Participant Compliance in Wear Time Between Five-layer and Comparator Dressing
Compliance with the 7-day wear time protocol, within the first critical week of treatment. Compliance is defined as participants who wore a dressing continuously from time of application until removal at Day 7 visit. This includes participants whose dressing did not have strikethrough up to Day 7 and those who wore their dressing until strikethrough at Day 7 when dressing was removed.
Time frame: 1 week
Population: Intent-to-treat (ITT) analysis set of superiority. Participants were combined into 2 cohorts: participants in the Five-layer vs Hydropolymer into one cohort, \& Five-layer vs Hydrocellular were similarly combined into a second cohort to allow for reporting and analysis in order to compare the % of participant in compliance with 7-day wear time protocol in the first week of treatment. Number of participants analyzed differ from baseline due to missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Five-layer vs Hydropolymer | % Participant Compliance in Wear Time Between Five-layer and Comparator Dressing | First week compliance rate - Comparator | 27.8 %participant |
| Five-layer vs Hydropolymer | % Participant Compliance in Wear Time Between Five-layer and Comparator Dressing | First week compliance rate - Five-layer | 52.9 %participant |
| Five-layer vs Hydrocellular | % Participant Compliance in Wear Time Between Five-layer and Comparator Dressing | First week compliance rate - Five-layer | 62.6 %participant |
| Five-layer vs Hydrocellular | % Participant Compliance in Wear Time Between Five-layer and Comparator Dressing | First week compliance rate - Comparator | 18.8 %participant |
p-value: <0.05Chi-squared
p-value: <0.05Chi-squared