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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02353507
Recruitment Status : Withdrawn
First Posted : February 2, 2015
Last Update Posted : April 27, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bandages Device: Opticell Ag+ Device: Aquacel Ag+ Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Opticell Ag+
Absorbent, antibacterial, barrier dressing
Device: Opticell Ag+
Active Comparator: Aquacel Ag+
Absorbent, antibacterial, barrier dressing
Device: Aquacel Ag+

Primary Outcome Measures :
  1. Wound Infection Rates [ Time Frame: Up to 21 days of use ]
  2. Days required for wound healing [ Time Frame: Up to 21 days of use ]

Secondary Outcome Measures :
  1. Pain Levels during Dressing Removal [ Time Frame: Up to 21 days ]
    Categorical scale of pain reported by Subject

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Medline Industries Identifier: NCT02353507    
Other Study ID Numbers: R14-054
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: February 2015
Additional relevant MeSH terms:
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Wounds and Injuries
Carboxymethylcellulose Sodium
Gastrointestinal Agents