Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects
Phase 4
Withdrawn
- Conditions
- Bandages
- Interventions
- Device: Opticell Ag+Device: Aquacel Ag+
- Registration Number
- NCT02353507
- Lead Sponsor
- Medline Industries
- 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 available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opticell Ag+ Opticell Ag+ Absorbent, antibacterial, barrier dressing Aquacel Ag+ Aquacel Ag+ Absorbent, antibacterial, barrier dressing
- Primary Outcome Measures
Name Time Method Wound Infection Rates Up to 21 days of use Days required for wound healing Up to 21 days of use
- Secondary Outcome Measures
Name Time Method Pain Levels during Dressing Removal Up to 21 days Categorical scale of pain reported by Subject