Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

Phase 1

Completed

• Conditions: Skin Graft
• Interventions: Other: Standard dressings; Biological: Autologous Platelet Rich Plasma; Biological: Keratinocyte suspension

• Registration Number: NCT00856934
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-03
• Study First Submitted: 2009-01-02
• Results First Submitted: 2009-01-02
• Status Verified: 2009-02
• Study First Submitted QC: 2009-02-05
• Results First Submitted QC: 2009-02-05
• Last Update Submitted: 2009-02-05
• Study First Posted: 2009-03-06
• Results First Posted: 2009-03-06
• Last Update Posted: 2009-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Skin graft donor sites total surface < 15% BSA
• Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area

Exclusion Criteria

• Patients treated with immunosuppressors
• Patients treated with corticoids
• Patients suffering from terminal renal insufficiency
• Patients suffering from severe peripheral arteriopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard dressings	Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
PRP	Autologous Platelet Rich Plasma	PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
PRP	Standard dressings	PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
PRP+K	Autologous Platelet Rich Plasma	Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
PRP+K	Keratinocyte suspension	Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
PRP+K	Standard dressings	Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.

Primary Outcome Measures

Name	Time	Method
Complete Wound Healing	Post operative day 5 and every other day thereafter	Time required for complete epithelialization in days

Secondary Outcome Measures

Name	Time	Method
Pain	Post operative day 5	Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.

Trial Locations

Locations (1)

Centre hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland