Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00856934
First received: January 2, 2009
Last updated: February 5, 2009
Last verified: February 2009
Results First Received: January 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Skin Graft
Interventions: Biological: Autologous Platelet Rich Plasma
Biological: Keratinocyte suspension
Other: Standard dressings

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
PRP Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
PRP+K Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.

Participant Flow:   Overall Study
    Control     PRP     PRP+K  
STARTED     15     15     15  
COMPLETED     15     15     15  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Control Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
PRP Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
PRP+K Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
Total Total of all reporting groups

Baseline Measures
    Control     PRP     PRP+K     Total  
Number of Participants  
[units: participants]
  15     15     15     45  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     15     14     12     41  
>=65 years     0     1     3     4  
Age  
[units: years]
Mean ± Standard Deviation
  42.5  ± 11.9     45.5  ± 15.3     46.9  ± 20.5     44.7  ± 16.2  
Gender  
[units: participants]
       
Female     4     6     10     20  
Male     11     9     5     25  



  Outcome Measures
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1.  Primary:   Complete Wound Healing   [ Time Frame: Post operative day 5 and every other day thereafter ]

2.  Secondary:   Pain   [ Time Frame: Post operative day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Wassim Raffoul
Organization: CHUV - CPR
phone: +41 21 314 25 05
e-mail: Wassim.Raffoul@chuv.ch


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
Study First Received: January 2, 2009
Results First Received: January 2, 2009
Last Updated: February 5, 2009
Health Authority: Switzerland: Swissmedic