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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-01

Brief Summary

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

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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.

Conditions

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Treatment of Skin Graft Donor Site

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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®.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Hospitalized burn patients

Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.

Group Type EXPERIMENTAL

Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.

Intervention Type OTHER

Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.

Interventions

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Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No