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ISRCTN
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ISRCTN34481461
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ClinicalTrials.gov identifier
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Public title
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The effect of locally applied autologous platelet-rich fibrin sealant on woundhealing
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Scientific title
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Acronym
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The IMPRA-project
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Serial number at source
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KF (01) 264835
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Study hypothesis
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Platelet-rich fibrin enhances and accelerates wound healing
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Denmark
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Disease/condition/study domain
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Cholelithiasis
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Participants - inclusion criteria
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Consecutive patients undergoing elective laparoscopic cholecystectomy, over 18 years old who have given written and verbal informed consent.
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Participants - exclusion criteria
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1. Not Danish-speaking
2. Demential
3. Pregnant or lactating women
4. Fertile women not using contraception
5. Patients on aspirin (acetylsalicylic acid [ASA]) or anticoagulants less than 7 days before surgery
6. Patients suffering from anaemia or coagulation disorders
7. Patients suffering from incompensated heart or lung disease
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Anticipated start date
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01/08/2005
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Anticipated end date
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01/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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Surgical wounds treated with trial product (platelet-rich fibrin) or control.
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Primary outcome measure(s)
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Collagen synthesis
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Secondary outcome measure(s)
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1. Woundstrength
2. Production of type I and III collagen mRNA
3. Histology
4. Growthfactors
5. Unwanted effects
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Sources of funding
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Vivolution A/S (Denmark)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20395860
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Contact name
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Dr
Lars Nannestad
Jørgensen
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Address
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Afd. K
Bispebjerg Hospital
Bispebjerg Bakke 23
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City/town
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Copenhagen
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Zip/Postcode
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2400 NV
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Country
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Denmark
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Tel
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+45 (0)3531 2856
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Fax
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+45 (0)3531 3911
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Email
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larsnjorgensen@hotmail.com
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Sponsor
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Vivolution A/S (Denmark)
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Address
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Blokken 45
DK-3460 Birkerod
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City/town
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Birkerod
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Zip/Postcode
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3460
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Country
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Denmark
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Tel
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+45 (0)4581 1962
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Fax
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+45 (0)4582 4800
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Email
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info@vivolution.com
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Sponsor website:
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http://www.vivolution.com
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Date applied
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29/07/2005
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Last edited
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17/05/2010
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Date ISRCTN assigned
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06/10/2005
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