Condition category
Digestive System
Date applied
29/07/2005
Date assigned
06/10/2005
Last edited
17/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vivolution.com

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

  1. 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.

Additional files

Editorial Notes