Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-07-31

Brief Summary

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The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands.

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Detailed Description

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Conditions

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Bandages

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyalomatrix

Sterile, single use, flexible, and conformable wound dressing comprised of a derivative of hyaluronic acid which acts as a three dimensional regenerative matrix.

Group Type ACTIVE_COMPARATOR

Hyalomatrix

Intervention Type DEVICE

Integra

Sterile, single use, wound care dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan

Group Type ACTIVE_COMPARATOR

Integra

Intervention Type DEVICE

Interventions

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Hyalomatrix

Intervention Type DEVICE

Integra

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written consent must be obtained
* First and/or second degree burns on both hands
* Subject must be enrolled within 48 hours of the injury occurrence.

Exclusion Criteria

* Subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation.
* Subject has a prognosis that indicates unlikely survival past the study period.
* Subject's diagnosis indicates third degree burns.
* Subject suffers from burns sustained as a result of an electrical/chemical injury or by frostbite.
* Subject suffers from any inhalation-related burn trauma.
* Subject suffers from ongoing bone fractures.
* Subject has a known sensitivity to materials containing silicone, hyaluronan, bovine collagen, or chondroitin and/or derivatives of these products.
* Subject has received any treatment prior to study enrollment that may, in the opinion of the Investigator, affect the outcome of the study.
* Subject suffers from a medical condition that may impede wound healing, above any beyond that which would typically be expected.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No