Trial Outcomes & Findings for Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds (NCT NCT03662997)
NCT ID: NCT03662997
Last Updated: 2021-04-01
Results Overview
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)
COMPLETED
NA
40 participants
4 weeks
2021-04-01
Participant Flow
40 participants were randomized and received treatment.
Participant milestones
| Measure |
Hydropolymer vs Five-layer
Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks
|
Five-layer vs Hydropolymer
Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks
|
Hydrocellular vs Five-layer
Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks
|
Five-layer vs Hydrocellular
Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
11
|
8
|
|
Overall Study
COMPLETED
|
11
|
8
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Hydropolymer vs Five-layer
Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks
|
Five-layer vs Hydropolymer
Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks
|
Hydrocellular vs Five-layer
Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks
|
Five-layer vs Hydrocellular
Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hydropolymer vs Five-layer
n=11 Participants
Hydropolymer Foam Dressing for 2 weeks, then Bordered Five-Layer Foam Dressing for 2 weeks
|
Five-layer vs Hydropolymer
n=8 Participants
Bordered Five-Layer Foam Dressing for 2 weeks, then Hydropolymer Foam Dressing for 2 weeks
|
Hydrocellular vs Five-layer
n=11 Participants
Hydrocellular Multi-Layer Foam Dressing for 2 weeks then Bordered Five-Layer Foam Dressing for weeks
|
Five-layer vs Hydrocellular
n=8 Participants
Bordered Five-Layer Foam Dressing for two weeks then Hydrocellular Multi-Layer Foam Dressing for two weeks
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=11 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=11 Participants
|
6 Participants
n=8 Participants
|
26 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=11 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=11 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=38 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=11 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=11 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=11 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=11 Participants
|
5 Participants
n=8 Participants
|
26 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
8 participants
n=8 Participants
|
11 participants
n=11 Participants
|
8 participants
n=8 Participants
|
38 participants
n=38 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 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.
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)
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=16 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% of Participants With Equal or Better Rate of Dressing Durability
Weeks 1 & 3 Five-layer equal or better
|
100.0 %participants
|
94.1 %participants
|
|
% of Participants With Equal or Better Rate of Dressing Durability
Weeks 2 & 4 Five-layer equal or better
|
69.2 %participants
|
73.3 %participants
|
PRIMARY outcome
Timeframe: Weeks 1 and 3Population: 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.
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)
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=14 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
Five-layer
|
43.8 %participants
|
35.3 %participants
|
|
% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
Comparator
|
12.5 %participants
|
5.6 %participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=16 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% 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
|
75.1 %participants
|
|
% 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
|
83.4 %participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=16 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% 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
|
87.6 %participants
|
|
% 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
|
58.3 %participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=16 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% 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
|
81.3 %participants
|
|
% 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
|
58.4 %participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=16 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% 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
|
70.6 %participants
|
|
% 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
|
73.3 %participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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%.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=16 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% 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
|
93.8 %participants
|
|
% 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
|
66.7 %participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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%.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=16 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% 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
|
91.6 %participants
|
|
% 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
|
93.8 %participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=14 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
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
|
-3.13 score on a scale
Standard Deviation 13.84
|
|
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
|
0.001 score on a scale
Standard Deviation 11.461
|
|
Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire
Change in Bodily Pain
|
-6.57 score on a scale
Standard Deviation 9.80
|
5.11 score on a scale
Standard Deviation 14.31
|
|
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
|
3.47 score on a scale
Standard Deviation 9.89
|
|
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
|
1.00 score on a scale
Standard Deviation 10.06
|
|
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
|
-2.61 score on a scale
Standard Deviation 5.35
|
|
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
|
-0.661 score on a scale
Standard Deviation 18.685
|
|
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
|
2.63 score on a scale
Standard Deviation 12.72
|
|
Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire
Change in Mental Health
|
-2.70 score on a scale
Standard Deviation 7.70
|
0.395 score on a scale
Standard Deviation 9.036
|
|
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
|
0.078 score on a scale
Standard Deviation 9.964
|
POST_HOC outcome
Timeframe: 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Five-layer vs Hydropolymer
n=14 Participants
The following two arms were combined into one cohort:
1. Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Five-layer vs Hydrocellular
n=18 Participants
The following two arms were combined into one cohort:
1. Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
2. Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|
|
% Participant Compliance in Wear Time Between Five-layer and Comparator Dressing
First week compliance rate - Five-layer
|
52.9 %participant
|
62.6 %participant
|
|
% Participant Compliance in Wear Time Between Five-layer and Comparator Dressing
First week compliance rate - Comparator
|
27.8 %participant
|
18.8 %participant
|
Adverse Events
Hydropolymer, Then Five-layer
Five-layer, Then Hydropolymer
Hydrocellular, Then Five-layer
Five-layer, Then Hydrocellular
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydropolymer, Then Five-layer
n=11 participants at risk
Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks
|
Five-layer, Then Hydropolymer
n=9 participants at risk
Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
|
Hydrocellular, Then Five-layer
n=11 participants at risk
Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks followed by Bordered Five-layer Foam Dressing for 2 weeks
|
Five-layer, Then Hydrocellular
n=9 participants at risk
Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Blister plantar midfoot
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
11.1%
1/9 • Number of events 1 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/9 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
|
General disorders
Pain due to compression
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
11.1%
1/9 • Number of events 1 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/9 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
|
General disorders
Increased pain to study limb
|
9.1%
1/11 • Number of events 1 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/9 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/9 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
|
Infections and infestations
Infection to study ulcer
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
22.2%
2/9 • Number of events 2 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/9 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
|
Skin and subcutaneous tissue disorders
Blister left plantar forefoot
|
9.1%
1/11 • Number of events 1 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/9 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
0.00%
0/11 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
11.1%
1/9 • Number of events 1 • Two weeks for each intervention.
Safety population included all participants who received at least one dressing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place