Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

Bandages Clinical Trial

— Hyalomatrix  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02363543
• Other study ID #: R14-090
• Status: Withdrawn
• Phase: Phase 4
• First received: January 28, 2015
• Last updated: August 29, 2017
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bandages

Intervention

Device:
• Hyalomatrix

• Integra

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Infection Rate		Up to 21 days
Primary	Number of days required for wound healing		Up to 21 days
Secondary	Range of Motion Scores	Analysis of Range of Motion Scores	Up to 21 days
Secondary	Physician Scores on Products Ease of Use	Analysis of physician scores	Up to 21 days