Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

NCT02363543 | Withdrawn Phase 4

• 1 other identifier: R14-090
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bandages

Outcome Measures

Primary Outcomes (2)

• Wound Infection Rate

  Up to 21 days

• Number of days required for wound healing

  Up to 21 days

Secondary Outcomes (2)

• Range of Motion Scores

  Up to 21 days

• Physician Scores on Products Ease of Use

  Up to 21 days

Study Arms (2)

Hyalomatrix

ACTIVE COMPARATOR

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

Integra

ACTIVE COMPARATOR

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

Device: Integra

Interventions

Hyalomatrix DEVICE

Hyalomatrix

Integra DEVICE

Integra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medline Industries: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 16, 2015
• Study Start: February 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 30, 2017

Record last verified: 2017-08