Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

Medline Industries

Status and phase: Withdrawn; Phase 4

Conditions: Bandages

Treatments: Device: Hyalomatrix; Device: Integra

Study type: Interventional

Funder types: Industry

Identifiers

NCT02363543

R14-090

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Hyalomatrix

Active Comparator group

Description:

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

Treatment:

Device: Hyalomatrix

Integra

Active Comparator group

Description:

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

Treatment:

Device: Integra