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

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ClinicalTrials.gov Identifier: NCT03662997
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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: 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

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




Primary Outcome Measures :
  1. Wound dressing durability/time (days) to dressing strikethrough [ Time Frame: Upto 4 weeks ]
    Measurement of wound dressing durability, as defined as the interval of time to dressing strikethrough and need for dressing change (dressing wear time [days]). This will be assessed by the judgement of the clinician and by photography.


Secondary Outcome Measures :
  1. Level of dressing saturation [ Time Frame: Up to 4 weeks ]

    Level of dressing saturation will be assessed subjectively, using the following scale:

    Unchanged - Dressing looks the same as when put on the wound. Partly Saturated - Dressing is <50% saturated with exudate but remains intact. Mostly Saturated - Dressing is >50% saturated with exudates. Strikethrough - Dressing is completely saturated and exudates have leaked outside the bandage.

    The outcome will be assessed twice weekly, from visit day 3 (-1/+2 days), up to four weeks (visit day 28, -1/+2 days).


  2. Exudate dispersion [ Time Frame: Up to 4 weeks ]

    The extent of exudate dispersion relating to the dressing pad will be measured using a 6-point scale (1-25% of pad; 26-50% of pad; 51-75% of pad; 76-100% of pad; saturated with no strikethrough; saturated with strikethrough).

    The outcome will be assessed twice weekly, from visit day 3 (-1/+2 days), up to four weeks (visit day 28, -1/+2 days).


  3. Wound surface area [ Time Frame: Up to 4 weeks ]

    Wound surface area, during wound management with each of the test dressings (in combination with standard care), will be measured serially using photo-digital planimetric software.

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  4. Rate of wound healing [ Time Frame: Up to 4 weeks ]

    Rate of wound healing will be measured as a percentage captured via photo-digital planimetry, during wound management with each of the test dressings (in combination with standard care).

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  5. Wound granulation [ Time Frame: Up to 4 weeks ]

    Wound granulation during wound management with each of the test dressings (in combination with standard care) will be measured using a 6-point scale (none; trace islands of granulation tissue, less than 25%; 25% - 49% wound base is covered with granulation tissue; 50% - 74% wound base is covered with granulation tissue; 75% - 99% wound base is covered with granulation tissue; 100% - wound base completely filled with granulation tissue).

    This outcome measure will be measured as a percentage of the wound, captured via photodigital planimetry and visual judgement by research doctor/nurse.

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  6. Non-viable tissue [ Time Frame: Up to 4 weeks ]

    Non-viable tissue (eschar, fibrin slough, both) during wound management with each of the test dressings (in combination with standard care) will be measured using a 5-point scale (none; less than 25%; 25% - 49%; 50% - 74%; 75% - 100%).

    This outcome measure will be measured as a percentage of the wound, captured via photodigital planimetry and visual judgement by research doctor/nurse.

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  7. Exudate amount [ Time Frame: Up to 4 weeks ]

    Exudate amount during wound management with each of the test dressings (in combination with standard care will be measured subjectively using a 4-point scale (none; scant/minimal; moderate; heavy).

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  8. Type of wound drainage [ Time Frame: Up to 4 weeks ]

    Type of wound drainage during wound management with each of the test dressings (in combination with standard care) will be measured subjectively using a 4-point scale (serous; sanguineous; serosanguinous; purulent).

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  9. Exudate absorption [ Time Frame: Up to 4 weeks ]

    Exudate absorption during wound management with each of the test dressings (in combination with standard care) will be measured subjectively using a 5-point scale (very poor; poor; good; very good; n/a).

    The outcome will be assessed twice weekly, from visit day 3 (-1/+2 days), up to four weeks (visit day 28, -1/+2 days).


  10. Wound odour [ Time Frame: Up to 4 weeks ]

    Wound odour (before and after cleansing) during wound management with each of the test dressings (in combination with standard care) will be measured subjectively using an 8-point scale (none; minimal; barely noticeable; moderate; noticeable but not offensive; moderate; offensive; putrid).

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  11. Condition of surrounding skin [ Time Frame: Up to 4 weeks ]

    Condition of surrounding skin during wound management with each of the test dressings (in combination with standard care) will be measured subjectively, based on the following pre-defined parameters:

    Condition of surrounding skin (healthy/not healthy)

    Signs of inflammation (erythema, edema, induration) (yes/no)

    Signs of skin irritation at dressing site (yes/no)

    Skin rash/skin erosion, eczema (yes/no)

    Stasis dermatitis (yes/no)

    Vesicular erosion (blistering) (yes/no)

    Skin maceration (none; slight; moderate; severe)

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  12. Local wound and skin pain [ Time Frame: Up to 4 weeks ]

    Local wound and skin pain will be evaluated using the Wong-Baker Faces Pain Rating Scale (pain rated on a scale of zero to ten, with zero being no pain and ten being the worst pain imaginable) before dressing removal, at dressing removal, and immediately after dressing removal.

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  13. Clinical signs/symptoms of acute infection [ Time Frame: Up to 4 weeks ]

    Clinical signs of infection will be assessed based on the following parameters:

    Increased pain and tenderness (yes/no)

    Increased warmth (yes/no)

    Sudden increase in ulcer size (yes/no)

    Is there localised Erythema (yes/no)

    Foul smelling exudates (yes/no)

    Does the wound bleed easily (yes/no)

    The outcome will be assessed weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).


  14. Investigator reported outcomes [ Time Frame: Up to 4 weeks ]

    The investigator will make subjective assessments of dressing performance based on a pre-defined list of questions using a five-point rating scale (very poor; poor; good; very good; n/a), 'yes/no' answers, or 'none/some' answers (for presence of material remnant).

    The outcome will be assessed at two weeks (visit day 14, -1/+2 days) and four weeks (visit day 28, -1/+2 days).


  15. Subject reported outcomes [ Time Frame: Up to 4 weeks ]

    Subject-centric outcomes will be measured subjectively based on a pre-defined list of questions relating to dressing comfort and conformability (assessed by the subjects), using a five-point rating scale (very poor; poor; good; very good; n/a).

    The outcome will be assessed at two weeks (visit day 14, -1/+2 days) and four weeks (visit day 28, -1/+2 days).


  16. Health related quality of life [ Time Frame: Up to 4 weeks ]

    Health related quality of life will be assessed using a 12-item Short Form Survey (SF12).

    The outcome will be assessed at the baseline visit (day 0), two weeks (visit day 14, -1/+2 days) and four weeks (visit day 28, -1/+2 days).


  17. Adverse events (AEs)/Adverse device effects (ADEs)/Serious adverse events (SAEs)/Serious adverse device effects (SADEs)/Device deficiencies (DDs) [ Time Frame: Up to 4 weeks ]

    The incidence of Adverse events (AEs)/Adverse device effects (ADEs)/Serious adverse events (SAEs)/Serious adverse device effects (SADEs)/Device deficiencies (DDs) during study period for each subject.

    The outcome will be assessed twice weekly, from baseline visit (day 0), up to four weeks (visit day 28, -1/+2 days).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662997


Contacts
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Contact: Global Clinical Research Director +46 31 722 30 00 info@monlycke.com

Locations
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United States, California
Center for Clinical Research, Inc. Recruiting
Castro Valley, California, United States, 94546
Contact: Gayana Sarkisova, CCRC    800-363-1069 ext 104    gayana@ccr-trials.com   
Principal Investigator: Alexander Reyzelman, DPO         
Center for Clinical Trials, Inc. Recruiting
San Francisco, California, United States, 94115
Contact: Gayana Sarkisova, CCRC    800-363-1063 ext 104    gayana@ccr-trials.com   
Principal Investigator: Alexander Reyzelman, DPO         
United States, New Jersey
Vascular and Wound Care Center Recruiting
Newark, New Jersey, United States, 07101
Contact: Oscar Alvarez, PhD    973-972-3556    alvareom@uhnj.org   
Principal Investigator: Oscar Alvarez, PhD         
Sub-Investigator: Mark Granick, MD         
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
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Principal Investigator: Oscar Alvarez Vascular and Wound Care Center, University Hospital, Newark, NJ, USA

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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT03662997     History of Changes
Other Study ID Numbers: MxBFlex02
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
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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