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

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

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

Conditions
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Burn Wounds - Partial Thickness (2nd Degree)

Intervention / Treatment
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* Procedure: aquacel AG hydrofiber versus acticoat burn dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aquacel AG hydrofiber<br> | Procedure: aquacel AG hydrofiber versus acticoat burn dressing<br>* Aquacel AG hydrofiber versus acticoat burn dressing will be compared.<br>|
| Experimental: Acticoat burn dressing<br> | Procedure: aquacel AG hydrofiber versus acticoat burn dressing<br>* Aquacel AG hydrofiber versus acticoat burn dressing will be compared.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn wounds - Silver Dressings - Bacterial Control