The effect of locally applied autologous platelet-rich fibrin sealant on woundhealing
| ISRCTN | ISRCTN34481461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34481461 |
| Protocol serial number | KF (01) 264835 |
| Sponsor | Vivolution A/S (Denmark) |
| Funder | Vivolution A/S (Denmark) |
- 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
Scientific
Afd. K
Bispebjerg Hospital
Bispebjerg Bakke 23
Copenhagen
2400 NV
Denmark
| Phone | +45 (0)3531 2856 |
|---|---|
| larsnjorgensen@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | The IMPRA-project |
| Study objectives | Platelet-rich fibrin enhances and accelerates wound healing |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cholelithiasis |
| Intervention | Surgical wounds treated with trial product (platelet-rich fibrin) or control. |
| Intervention type | Other |
| Primary outcome measure(s) |
Collagen synthesis |
| Key secondary outcome measure(s) |
1. Woundstrength |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | Consecutive patients undergoing elective laparoscopic cholecystectomy, over 18 years old who have given written and verbal informed consent. |
| Key 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 |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Afd. K
Copenhagen
2400 NV
Denmark
2400 NV
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
