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

Primary Purpose

Burn Wounds - Partial Thickness (2nd Degree)

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
aquacel AG hydrofiber versus acticoat burn dressing
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Wounds - Partial Thickness (2nd Degree) focused on measuring Burn wounds - Silver Dressings - Bacterial Control

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

aquacel AG hydrofiber

Acticoat burn dressing

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days

Secondary Outcome Measures

Comparison of blood silver levels
Percentage of genetically-acquired resistance to silver
Healing time comparison
Scar quality assessment
Cost-effectiveness
Health related quality of life

Full Information

First Posted
June 21, 2006
Last Updated
December 18, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00343824
Brief Title
Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
Official Title
Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2006 (Actual)
Primary Completion Date
July 31, 2010 (Actual)
Study Completion Date
July 31, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wounds - Partial Thickness (2nd Degree)
Keywords
Burn wounds - Silver Dressings - Bacterial Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aquacel AG hydrofiber
Arm Type
Experimental
Arm Title
Acticoat burn dressing
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
aquacel AG hydrofiber versus acticoat burn dressing
Intervention Description
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Comparison of blood silver levels
Time Frame
Every week until woundhealing. In folluw-up: at 3, 6 and 12 months
Title
Percentage of genetically-acquired resistance to silver
Time Frame
Once after wound closure.
Title
Healing time comparison
Time Frame
Every 3 days until healing
Title
Scar quality assessment
Time Frame
At 1, 3, 6 and 12 months after wound closure
Title
Cost-effectiveness
Time Frame
Once after wound closure.
Title
Health related quality of life
Time Frame
At 1, 3, 6 and 12 months after wound closure

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Monstrey, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

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

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