Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Chronic Wound
• Intervention / Treatment: Device: Bordered Five-Layer Foam Dressing; Device: Hydropolymer Foam Dressing; Device: Hydrocellular Multi-Layer Foam Dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Castro Valley, California, United States, 94546
      • Center for Clinical Research, Inc.
    • San Francisco, California, United States, 94115
      • Center for Clinical Trials, Inc.
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • Vascular and Wound Care Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15222
      • SerenaGroup Research Foundation
    • Pittsburgh, Pennsylvania, United States, 15232
      • SerenaGroup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Five-layer vs Hydropolymer; Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks.	Device: Bordered Five-Layer Foam Dressing; Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology; Other Names: Five-layer; Device: Hydropolymer Foam Dressing; Hydropolymer, adhesive foam island dressing; Other Names: Hydropolymer
ACTIVE_COMPARATOR: Hydropolymer vs Five-layer; Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks	Device: Bordered Five-Layer Foam Dressing; Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology; Other Names: Five-layer; Device: Hydropolymer Foam Dressing; Hydropolymer, adhesive foam island dressing; Other Names: Hydropolymer
ACTIVE_COMPARATOR: Five-layer vs Hydrocellular; Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks.	Device: Bordered Five-Layer Foam Dressing; Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology; Other Names: Five-layer; Device: Hydrocellular Multi-Layer Foam Dressing; Multi-layered, hydrocellular foam dressing with silicone adhesive; Other Names: Hydrocellular
ACTIVE_COMPARATOR: Hydrocellular vs Five-layer; Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks	Device: Bordered Five-Layer Foam Dressing; Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology; Other Names: Five-layer; Device: Hydrocellular Multi-Layer Foam Dressing; Multi-layered, hydrocellular foam dressing with silicone adhesive; Other Names: Hydrocellular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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)	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)	Weeks 1 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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.	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.	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.	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.	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%.	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%.	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.	4 weeks

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Oscar Alvarez, Vascular and Wound Care Center, University Hospital, Newark, NJ, USA

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2019
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): November 15, 2019

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Chronic wound; Diabetic Foot Ulcer; Venous Leg Ulcer; Wound dressing
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: MxBFlex02

Drug and device information, study documents

• 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