Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings

December 18, 2022 updated by: University Hospital, Ghent
This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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

No older than 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Burn wounds with flux values, measured by Laser Doppler Imaging, corresponding with expected healing time between 7 and 21 days, flux values between 200 and 1000 (red-pink or pink-yellow-green colour)
  • Wounds treated with a hydrocolloid paste prior to LDI
  • Possibility to follow the complete treatment schedule until wound healing and participation on complete follow-up schedule
  • Informed consent
  • Partial thickness burns with TBSE < 40%

Exclusion Criteria:

  • Mean flux values < 200 or > 1000
  • TBSA > 40%
  • Impossibility to debride necrotic skin prior to LDI measurement
  • Wounds treated with any topical ointments or dressings other than hydrocolloid prior to LDI
  • Not following the complete treatment schedule or missing some evaluations during the follow-up period
  • Patient has any condition that seriously compromises the patient's ability to complete the study
  • Patient has participated in another study using an investigational drug within the previous 30 days
  • Patient has one or more medical condition(s)that in the opinion of the investigator would make the patient an inappropriate candidate for this study
  • The plastic surgeon decides that surgery is necessary due to unusual circumstances
  • Patient wish to decline from the study
  • No informed consent
  • Full thickness burns

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aquacel AG hydrofiber
Procedure: aquacel AG hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
Experimental: Acticoat burn dressing
Procedure: aquacel AG hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
Time Frame: Over a period of 21 days
Over a period of 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of blood silver levels
Time Frame: Every week until woundhealing. In folluw-up: at 3, 6 and 12 months
Every week until woundhealing. In folluw-up: at 3, 6 and 12 months
Percentage of genetically-acquired resistance to silver
Time Frame: Once after wound closure.
Once after wound closure.
Healing time comparison
Time Frame: Every 3 days until healing
Every 3 days until healing
Scar quality assessment
Time Frame: At 1, 3, 6 and 12 months after wound closure
At 1, 3, 6 and 12 months after wound closure
Cost-effectiveness
Time Frame: Once after wound closure.
Once after wound closure.
Health related quality of life
Time Frame: At 1, 3, 6 and 12 months after wound closure
At 1, 3, 6 and 12 months after wound closure

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

November 1, 2006

Primary Completion (Actual)

July 31, 2010

Study Completion (Actual)

July 31, 2010

Study Registration Dates

First Submitted

June 21, 2006

First Submitted That Met QC Criteria

June 21, 2006

First Posted (Estimate)

June 23, 2006

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/224

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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