Clinical trial NCT00856934: Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing
Official title: A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Graft
Keywords: Skin graft donor site healing
skin
wound
platelet concentrate
keratinocytes
burns
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complete Wound Healing
timeFrame: Post operative day 5 and every other day thereafter
Secondary outcomes:
measure: Pain
timeFrame: Post operative day 5
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: CHUV - CPR
name: Wassim Raffoul, PD, MER
role: PRINCIPAL_INVESTIGATOR
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