NCT03662997

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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. 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

• Chronic Wound
• Venous Leg Ulcer
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Bordered Five-Layer Foam Dressing	Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology
DEVICE	Hydropolymer Foam Dressing	Hydropolymer, adhesive foam island dressing
DEVICE	Hydrocellular Multi-Layer Foam Dressing	Multi-layered, hydrocellular foam dressing with silicone adhesive

Timeline

• Start date: 2019-03-19
• Primary completion: 2019-10-01
• Completion: 2019-11-15
• First posted: 2018-09-10
• Last updated: 2021-04-01
• Results posted: 2021-04-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study