The effect of locally applied autologous platelet-rich fibrin sealant on woundhealing

ISRCTN ISRCTN34481461
DOI https://doi.org/10.1186/ISRCTN34481461
Secondary identifying numbers KF (01) 264835
Submission date
29/07/2005
Registration date
06/10/2005
Last edited
17/05/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lars Nannestad Jørgensen
Scientific

Afd. K
Bispebjerg Hospital
Bispebjerg Bakke 23
Copenhagen
2400 NV
Denmark

Phone +45 (0)3531 2856
Email larsnjorgensen@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymThe IMPRA-project
Study objectivesPlatelet-rich fibrin enhances and accelerates wound healing
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCholelithiasis
InterventionSurgical wounds treated with trial product (platelet-rich fibrin) or control.
Intervention typeOther
Primary outcome measureCollagen synthesis
Secondary outcome measures1. Woundstrength
2. Production of type I and III collagen mRNA
3. Histology
4. Growthfactors
5. Unwanted effects
Overall study start date01/08/2005
Completion date01/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteriaConsecutive patients undergoing elective laparoscopic cholecystectomy, over 18 years old who have given written and verbal informed consent.
Key exclusion criteria1. 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
Date of first enrolment01/08/2005
Date of final enrolment01/09/2006

Locations

Countries of recruitment

  • Denmark

Study participating centre

Afd. K
Copenhagen
2400 NV
Denmark

Sponsor information

Vivolution A/S (Denmark)
Industry

Blokken 45
DK-3460 Birkerod
Birkerod
3460
Denmark

Phone +45 (0)4581 1962
Email info@vivolution.com
Website http://www.vivolution.com
ROR logo "ROR" https://ror.org/010knjd35

Funders

Funder type

Industry

Vivolution A/S (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2010 Yes No