Comparison of Hyalomatrix and Integra Wound Matrix on Bur... | NCT02363543

Studies
Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds

NCT02363543

Sponsor

Medline Industries

Status

Withdrawn

Last Update Posted

Aug 30, 2017Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Bandages

Interventions

Hyalomatrix
Integra

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision to not to proceed

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

May 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Jan 28, 2015

First Submission Date that Met QC Criteria

Feb 9, 2015

First Posted Date

Feb 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2017

Last Update Posted Date

Aug 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hyalomatrix	Device		Hyalomatrix
Integra

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided