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

Rambam Health Care Campus

Status

Withdrawn

Conditions

Treatment of Skin Graft Donor Site

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04749940

0007-21

Details and patient eligibility

About

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

Full 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®.

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.