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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662997
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE March 19, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Official Title  ICMJE A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Chronic Wound
  • Venous Leg Ulcer
  • Diabetic Foot Ulcer
Intervention  ICMJE
  • 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
  • Device: Hydrocellular Multi-Layer Foam Dressing
    Multi-layered, hydrocellular foam dressing with silicone adhesive
    Other Name: Hydrocellular
Study Arms  ICMJE
  • Active Comparator: Hydropolymer vs Five-layer
    Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-Layer Foam Dressing for 2 weeks
    Interventions:
    • Device: Bordered Five-Layer Foam Dressing
    • Device: Hydropolymer Foam Dressing
  • Active Comparator: Five-layer vs Hydropolymer
    Bordered Five-Layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks
    Interventions:
    • Device: Bordered Five-Layer Foam Dressing
    • Device: Hydropolymer Foam Dressing
  • 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
    Interventions:
    • Device: Bordered Five-Layer Foam Dressing
    • Device: Hydrocellular Multi-Layer Foam Dressing
  • 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
    Interventions:
    • Device: Bordered Five-Layer Foam Dressing
    • Device: Hydrocellular Multi-Layer Foam Dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
41
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
40
Actual Study Completion Date  ICMJE November 15, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662997
Other Study ID Numbers  ICMJE MxBFlex02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Molnlycke Health Care AB
Study Sponsor  ICMJE Molnlycke Health Care AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oscar Alvarez Vascular and Wound Care Center, University Hospital, Newark, NJ, USA
PRS Account Molnlycke Health Care AB
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP