Contact information
Type
Scientific
Primary contact
Dr Lars Nannestad Jørgensen
ORCID ID
Contact details
Afd. K
Bispebjerg Hospital
Bispebjerg Bakke 23
Copenhagen
2400 NV
Denmark
+45 (0)3531 2856
larsnjorgensen@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KF (01) 264835
Study information
Scientific title
Acronym
The IMPRA-project
Study hypothesis
Platelet-rich fibrin enhances and accelerates wound healing
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cholelithiasis
Intervention
Surgical wounds treated with trial product (platelet-rich fibrin) or control.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Collagen synthesis
Secondary outcome measures
1. Woundstrength
2. Production of type I and III collagen mRNA
3. Histology
4. Growthfactors
5. Unwanted effects
Overall trial start date
01/08/2005
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Consecutive patients undergoing elective laparoscopic cholecystectomy, over 18 years old who have given written and verbal informed consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
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
Recruitment start date
01/08/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Denmark
Trial participating centre
Afd. K
Copenhagen
2400 NV
Denmark
Sponsor information
Organisation
Vivolution A/S (Denmark)
Sponsor details
Blokken 45
DK-3460 Birkerod
Birkerod
3460
Denmark
+45 (0)4581 1962
info@vivolution.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Vivolution A/S (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20395860
Publication citations
-
Results
Danielsen PL, Agren MS, Jorgensen LN, Platelet-rich fibrin versus albumin in surgical wound repair: a randomized trial with paired design., Ann. Surg., 2010, 251, 5, 825-831, doi: 10.1097/SLA.0b013e3181d3548c.