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

Primary Purpose

Bandages

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Opticell Ag+
Aquacel Ag+
Sponsored by
Medline Industries
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bandages

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Opticell Ag+

    Aquacel Ag+

    Arm Description

    Absorbent, antibacterial, barrier dressing

    Absorbent, antibacterial, barrier dressing

    Outcomes

    Primary Outcome Measures

    Wound Infection Rates
    Days required for wound healing

    Secondary Outcome Measures

    Pain Levels during Dressing Removal
    Categorical scale of pain reported by Subject

    Full Information

    First Posted
    January 28, 2015
    Last Updated
    April 25, 2016
    Sponsor
    Medline Industries
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02353507
    Brief Title
    Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medline Industries

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bandages

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Opticell Ag+
    Arm Type
    Active Comparator
    Arm Description
    Absorbent, antibacterial, barrier dressing
    Arm Title
    Aquacel Ag+
    Arm Type
    Active Comparator
    Arm Description
    Absorbent, antibacterial, barrier dressing
    Intervention Type
    Device
    Intervention Name(s)
    Opticell Ag+
    Intervention Type
    Device
    Intervention Name(s)
    Aquacel Ag+
    Primary Outcome Measure Information:
    Title
    Wound Infection Rates
    Time Frame
    Up to 21 days of use
    Title
    Days required for wound healing
    Time Frame
    Up to 21 days of use
    Secondary Outcome Measure Information:
    Title
    Pain Levels during Dressing Removal
    Description
    Categorical scale of pain reported by Subject
    Time Frame
    Up to 21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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