Phase 1
N=45
Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing
Skin Graft
Bottom Line
View on ClinicalTrials.gov: NCT00856934 ↗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
| Outcome | Result | p-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
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.