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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.
 
ClinicalTrials.gov Identifier: NCT02353507
Recruitment Status : Withdrawn
First Posted : February 2, 2015
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Tracking Information
First Submitted Date  ICMJE January 28, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
  • Wound Infection Rates [ Time Frame: Up to 21 days of use ]
  • Days required for wound healing [ Time Frame: Up to 21 days of use ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • Wound Infection Rates [ Time Frame: Up to 21 days of use ]
  • Wound Healing Rates [ Time Frame: Up to 21 days of use ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
Pain Levels during Dressing Removal [ Time Frame: Up to 21 days ]
Categorical scale of pain reported by Subject
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
Comparable Pain Levels during Dressing Removal [ Time Frame: Up to 21 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bandages
Intervention  ICMJE
  • Device: Opticell Ag+
  • Device: Aquacel Ag+
Study Arms  ICMJE
  • Active Comparator: Opticell Ag+
    Absorbent, antibacterial, barrier dressing
    Intervention: Device: Opticell Ag+
  • Active Comparator: Aquacel Ag+
    Absorbent, antibacterial, barrier dressing
    Intervention: Device: Aquacel Ag+
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 25, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2015)
30
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353507
Other Study ID Numbers  ICMJE R14-054
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medline Industries
Study Sponsor  ICMJE Medline Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medline Industries
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP