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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02353507

Enrollment

Registered

2015-02-02

Start date

2015-02-28

Completion date

2016-04-30

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bandages

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.

Interventions

DEVICEOpticell Ag+

DEVICEAquacel Ag+

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026