Burn Wounds - Partial Thickness (2nd Degree)
Conditions
Keywords
Burn wounds - Silver Dressings - Bacterial Control
Brief summary
This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.
Interventions
PROCEDUREaquacel AG hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Percentage of genetically-acquired resistance to silver | Once after wound closure. |
| Healing time comparison | Every 3 days until healing |
| Comparison of blood silver levels | Every week until woundhealing. In folluw-up: at 3, 6 and 12 months |
| Cost-effectiveness | Once after wound closure. |
| Health related quality of life | At 1, 3, 6 and 12 months after wound closure |
| Scar quality assessment | At 1, 3, 6 and 12 months after wound closure |
Countries
Belgium
Outcome results
None listed