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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02363543
Recruitment Status : Withdrawn (Sponsor decision to not to proceed)
First Posted : February 16, 2015
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):
Medline Industries

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.

Condition or disease Intervention/treatment Phase
Bandages Device: Hyalomatrix Device: Integra Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2016
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Wound Infection Rate [ Time Frame: Up to 21 days ]
  2. Number of days required for wound healing [ Time Frame: Up to 21 days ]

Secondary Outcome Measures :
  1. Range of Motion Scores [ Time Frame: Up to 21 days ]
    Analysis of Range of Motion Scores

  2. Physician Scores on Products Ease of Use [ Time Frame: Up to 21 days ]
    Analysis of physician scores

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Medline Industries Identifier: NCT02363543    
Other Study ID Numbers: R14-090
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017