Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds (Hyalomatrix)

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.

Study Overview

• Status: Withdrawn
• Conditions: Bandages
• Intervention / Treatment: Device: Hyalomatrix; Device: Integra

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyalomatrix; Sterile, single use, flexible, and conformable wound dressing comprised of a derivative of hyaluronic acid which acts as a three dimensional regenerative matrix.	Device: Hyalomatrix
Active Comparator: Integra; Sterile, single use, wound care dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan	Device: Integra

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medline Industries

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 16, 2015

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: R14-090