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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-19

Study Completion Date

2019-11-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Wound Venous Leg Ulcer Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Five-layer vs Hydropolymer

Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks.

Group Type ACTIVE_COMPARATOR

Bordered Five-Layer Foam Dressing

Intervention Type DEVICE

Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology

Hydropolymer Foam Dressing

Intervention Type DEVICE

Hydropolymer, adhesive foam island dressing

Hydropolymer vs Five-layer

Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks

Group Type ACTIVE_COMPARATOR

Bordered Five-Layer Foam Dressing

Intervention Type DEVICE

Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology

Hydropolymer Foam Dressing

Intervention Type DEVICE

Hydropolymer, adhesive foam island dressing

Five-layer vs Hydrocellular

Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks.

Group Type ACTIVE_COMPARATOR

Bordered Five-Layer Foam Dressing

Intervention Type DEVICE

Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology

Hydrocellular Multi-Layer Foam Dressing

Intervention Type DEVICE

Multi-layered, hydrocellular foam dressing with silicone adhesive

Hydrocellular vs Five-layer

Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks

Group Type ACTIVE_COMPARATOR

Bordered Five-Layer Foam Dressing

Intervention Type DEVICE

Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology

Hydrocellular Multi-Layer Foam Dressing

Intervention Type DEVICE

Multi-layered, hydrocellular foam dressing with silicone adhesive

Interventions

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Bordered Five-Layer Foam Dressing

Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology

Intervention Type DEVICE

Hydropolymer Foam Dressing

Hydropolymer, adhesive foam island dressing

Intervention Type DEVICE

Hydrocellular Multi-Layer Foam Dressing

Multi-layered, hydrocellular foam dressing with silicone adhesive

Intervention Type DEVICE

Other Intervention Names

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Five-layer Hydropolymer Hydrocellular

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No