A Multi-Center, Randomized, Comparison Study of a Chitosan (Opticell Ag+) Silver Dressing and a Sodium Carboxymethylcellulose (Aquacel® Ag+) Silver Dressing on Burn Wounds in Pediatrics and Adults Subjects

Medline Industries0 sitesFebruary 2015

ConditionsBandages

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Bandages
Sponsor: Medline Industries
Primary Endpoint: Wound Infection Rates
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

April 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medline Industries

Responsible Party

Sponsor

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.