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

• ClinicalTrials.gov Identifier: NCT03662997
• Recruitment Status: Completed
• First Posted: September 10, 2018
• Results First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Sponsor: Molnlycke Health Care AB
• Information provided by (Responsible Party): Molnlycke Health Care AB

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.

Condition or disease	Intervention/treatment	Phase
Chronic Wound; Venous Leg Ulcer; Diabetic Foot Ulcer	Device: Bordered Five-Layer Foam Dressing; Device: Hydropolymer Foam Dressing; Device: Hydrocellular Multi-Layer Foam Dressing	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 19, 2019
• Actual Primary Completion Date: October 1, 2019
• Actual Study Completion Date: November 15, 2019

Arms and Interventions

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 Name: Five-layer; Device: Hydropolymer Foam Dressing; Hydropolymer, adhesive foam island dressing; Other Name: 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 Name: Five-layer; Device: Hydropolymer Foam Dressing; Hydropolymer, adhesive foam island dressing; Other Name: 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 Name: Five-layer; Device: Hydrocellular Multi-Layer Foam Dressing; Multi-layered, hydrocellular foam dressing with silicone adhesive; Other Name: 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 Name: Five-layer; Device: Hydrocellular Multi-Layer Foam Dressing; Multi-layered, hydrocellular foam dressing with silicone adhesive; Other Name: Hydrocellular

Outcome Measures

Primary Outcome Measures :

1. % of Participants With Equal or Better Rate of Dressing Durability [ Time Frame: 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)
2. % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 [ Time Frame: 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 Outcome Measures :

1. % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer [ Time Frame: 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.
2. % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer [ Time Frame: 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.
3. % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer [ Time Frame: 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.
4. % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings [ Time Frame: 4 weeks ]
   Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through.
5. % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation [ Time Frame: 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%.
6. % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) [ Time Frame: 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%.
7. Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Center for Clinical Research, Inc.

Castro Valley, California, United States, 94546

Center for Clinical Trials, Inc.

San Francisco, California, United States, 94115

United States, New Jersey

Vascular and Wound Care Center

Newark, New Jersey, United States, 07101

United States, Pennsylvania

SerenaGroup Research Foundation

Pittsburgh, Pennsylvania, United States, 15222

SerenaGroup

Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

Molnlycke Health Care AB

Investigators

• Principal Investigator: Oscar Alvarez; Vascular and Wound Care Center, University Hospital, Newark, NJ, USA

  Study Documents (Full-Text)

Documents provided by Molnlycke Health Care AB:

Study Protocol and Statistical Analysis Plan  [PDF] March 15, 2019

More Information

• Responsible Party: Molnlycke Health Care AB
• ClinicalTrials.gov Identifier: NCT03662997
• Other Study ID Numbers: MxBFlex02
• First Posted: September 10, 2018
• Results First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Last Verified: January 2020

• 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

Keywords provided by Molnlycke Health Care AB:

Chronic wound; Venous Leg Ulcer; Diabetic Foot Ulcer; Wound dressing

Additional relevant MeSH terms:

Diabetic Foot; Varicose Ulcer; Foot Ulcer; Leg Ulcer; Ulcer; Wounds and Injuries; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Varicose Veins