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

NCT03662997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-01

Study results available
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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.

Conditions

  • Chronic Wound
  • Venous Leg Ulcer
  • Diabetic Foot Ulcer

Interventions

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

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Oscar Alvarez · Vascular and Wound Care Center, University Hospital, Newark, NJ, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2019-10-01
Completion
2019-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662997 on ClinicalTrials.gov