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

Not Applicable

Withdrawn

• Conditions: Treatment of Skin Graft Donor Site
• Interventions: Other: Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.

• Registration Number: NCT04749940
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-11
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-19
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hospitalized burn patients	Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.	Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.

Primary Outcome Measures

Name	Time	Method
Change of percentage of wound healing after 1 week, 2 weeks and 3 weeks.	3 weeks	Primary variables will be analyzed using ImageJ software.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel