Comparison of Chitosan and Carboxymethylcellulose Silver... | NCT02353507

Studies
Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects

NCT02353507

Sponsor

Medline Industries

Status

Withdrawn

Last Update Posted

Apr 27, 2016Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Bandages

Interventions

Opticell Ag+
Aquacel Ag+

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jan 28, 2015

First Submission Date that Met QC Criteria

Jan 28, 2015

First Posted Date

Feb 2, 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

Apr 25, 2016

Last Update Posted Date

Apr 27, 2016Estimated

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 prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.

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
Opticell Ag+	Active Comparator	Absorbent, antibacterial, barrier dressing	Device: Opticell Ag+
Aquacel Ag+	Active Comparator	Absorbent, antibacterial, barrier dressing	Device: Aquacel Ag+

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opticell Ag+	Device		Opticell Ag+
Aquacel Ag+

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound Infection Rates		Up to 21 days of use
Days required for wound healing		Up to 21 days of use

Secondary Outcomes

Measure	Description	Time Frame
Pain Levels during Dressing Removal	Categorical scale of pain reported by Subject	Up to 21 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inpatient status at the site
Written consent obtained from the subject
Burn injury must have been incurred within 36 hours prior to enrollment.
Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths
Burn injury must exceed 3% total body surface area.

Exclusion Criteria:

Subject is pregnant.
Bone fractures.
Inhalation-related trauma.
Sensitive and/or allergic to materials containing silver.
Burn injury exceeds 40% total body surface area.
Burn injury diagnosis indicates deep partial or full thickness wounds.
Burn a result of electrical/chemical injury or frostbite.
An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided