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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology
Hydropolymer, adhesive foam island dressing
Multi-layered, hydrocellular foam dressing with silicone adhesive
Center for Clinical Research, Inc.
Castro Valley, California, United States
Center for Clinical Trials, Inc.
San Francisco, California, United States
Vascular and Wound Care Center
Newark, New Jersey, United States
SerenaGroup Research Foundation
Pittsburgh, Pennsylvania, United States
% 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
% 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
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer
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SerenaGroup
Pittsburgh, Pennsylvania, United States
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
% 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
% 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
% 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
% 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
% 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
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