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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bandages

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Opticell Ag+

Absorbent, antibacterial, barrier dressing

Group Type ACTIVE_COMPARATOR

Opticell Ag+

Intervention Type DEVICE

Aquacel Ag+

Absorbent, antibacterial, barrier dressing

Group Type ACTIVE_COMPARATOR

Aquacel Ag+

Intervention Type DEVICE

Interventions

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Opticell Ag+

Intervention Type DEVICE

Aquacel Ag+

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No