PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site

Study Overview
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Brief Summary
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PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site: A Non-Inferiority Trial

Detailed Description
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A prospective single-blind study, where the evaluator is blinded to the treatment. Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®. 3 days after surgery the patients will be asked to complete a VAS questionnaire. A week and 2 weeks after surgery, patients will have their dressing changed as in the first treatment, and will answer VAS(9) and bluebelle(10) questionnaires. The wound will be photographed again for follow-up. Three weeks, 6 weeks and 3 months after surgery the scar in the donor area will be evaluated. The photographs will be shown to the blinded evaluator, to evaluate wound healing by epithelialization estimation.

Official Title
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PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site: A Non-Inferiority Trial

Conditions
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Treatment of Skin Graft Donor Site

Intervention / Treatment
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* Other: Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with a small burn (2-20% TBSA), who require skin grafting. Exclusion Criteria: Patients younger than 18 years Patients refusing hospitalization Patients with heavily infected wounds, which are the probable cause of bacteremia or sepsis. Patients with diabetes mellitus or peripheral vascular disease Patients under treatment of steroids or other immunosuppressing agents Patients with infectious diseases, i.e., HIV, HCV or HBV. Patients who are smokers. Patients with a known allergy to the dressing. Female patients who are pregnant or nursing, psychiatric patients and soldiers.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective single-blind study, where the evaluator is blinded to the treatment. Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospitalized burn patients<br>Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®. | Other: Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.<br>* Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of percentage of wound healing after 1 week, 2 weeks and 3 weeks. | Primary variables will be analyzed using ImageJ software. | 3 weeks |