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

April 25, 2016 updated by: Medline Industries

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound Infection Rates
Time Frame: Up to 21 days of use
Up to 21 days of use
Days required for wound healing
Time Frame: Up to 21 days of use
Up to 21 days of use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Levels during Dressing Removal
Time Frame: Up to 21 days
Categorical scale of pain reported by Subject
Up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R14-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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