Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing
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ClinicalTrials.gov Identifier: NCT00856934 |
Recruitment Status
:
Completed
First Posted
: March 6, 2009
Results First Posted
: March 6, 2009
Last Update Posted
: March 6, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skin Graft | Biological: Autologous Platelet Rich Plasma Biological: Keratinocyte suspension Other: Standard dressings | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial. |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | March 2006 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control
Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
|
Other: Standard dressings
Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
|
Experimental: PRP
PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
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Biological: Autologous Platelet Rich Plasma
Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.
Other: Standard dressings
Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
|
Experimental: PRP+K
Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
|
Biological: Autologous Platelet Rich Plasma
Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.
Biological: Keratinocyte suspension
Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.
Other: Standard dressings
Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
|
- Complete Wound Healing [ Time Frame: Post operative day 5 and every other day thereafter ]
- Pain [ Time Frame: Post operative day 5 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856934
Switzerland | |
Centre hospitalier Universitaire Vaudois | |
Lausanne, Vaud, Switzerland, 1011 |
Principal Investigator: | Wassim Raffoul, PD, MER | CHUV - CPR |
Publications of Results:
Other Publications:
Responsible Party: | Wassim Raffoul / Medecin Chef, Service de Chirurgie Plastique et Reconstructrice, CHUV |
ClinicalTrials.gov Identifier: | NCT00856934 History of Changes |
Other Study ID Numbers: |
132/03 |
First Posted: | March 6, 2009 Key Record Dates |
Results First Posted: | March 6, 2009 |
Last Update Posted: | March 6, 2009 |
Last Verified: | February 2009 |
Keywords provided by Centre Hospitalier Universitaire Vaudois:
Skin graft donor site healing skin wound |
platelet concentrate keratinocytes burns |