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Phase 1 N=45 Randomized Treatment

Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

Skin Graft

Enrolled (actual)
45
Serious AEs
Results posted
Mar 2009
Primary outcome: Primary: Complete Wound Healing — 13.9; 7.2; 5.7 Days — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Autologous Platelet Rich Plasma (Biological); Keratinocyte suspension (Biological); Standard dressings (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Centre Hospitalier Universitaire Vaudois
Primary completion
Mar 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Complete Wound Healing
13.9; 7.2; 5.7 0.05
SECONDARY
Pain
7.2; 1.5; 0.4 0.05

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00856934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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