Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02363543

Acronym

Hyalomatrix

Enrollment

Registered

2015-02-16

Start date

2016-02-29

Completion date

2016-07-31

Last updated

2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bandages

Brief summary

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.

Interventions

DEVICEHyalomatrix

DEVICEIntegra

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Wound Infection Rate	Up to 21 days
Number of days required for wound healing	Up to 21 days

Secondary

Measure	Time frame	Description
Range of Motion Scores	Up to 21 days	Analysis of Range of Motion Scores
Physician Scores on Products Ease of Use	Up to 21 days	Analysis of physician scores

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026