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

Medline Industries

Status and phase

Withdrawn

Phase 4

Conditions

Bandages

Treatments

Device: Opticell Ag+

Device: Aquacel Ag+

Study type

Interventional

Funder types

Industry

Identifiers

NCT02353507

R14-054

Details and patient eligibility

About

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.

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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.