Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects
Phase 4
Withdrawn
- Conditions
- Bandages
- 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- WITHDRAWN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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which chitosan and carboxymethylcellulose silver dressings promote wound healing in burn injuries?
How does the efficacy of Opticell Ag+ compare to standard-of-care silver sulfadiazine in managing exudative burn wounds?
Are there specific biomarkers that can predict better outcomes with chitosan-based versus carboxymethylcellulose-based silver dressings in burn patients?
What are the potential adverse events associated with prolonged use of Opticell Ag+ and Aquacel® Ag+ in pediatric burn wound management?
How do chitosan silver dressings compare to other antimicrobial wound care technologies like nanosilver or honey-based dressings in burn treatment?