The effect of locally applied platelet-rich fibrin on donor sites and recipient sites after split-thickness skin transplantation
| ISRCTN | ISRCTN01737461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01737461 |
| Secondary identifying numbers | (KF) 01286728 |
- Submission date
- 09/01/2006
- Registration date
- 17/02/2006
- Last edited
- 24/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Ms Patricia Danielsen
Scientific
Scientific
Bispebjerg Hospital
Afdeling K
Bispebjerg Bakke 23
2400 Kobenhavn NV
2400
Denmark
| Phone | +45 (0)3531 3463 |
|---|---|
| patriciadanielsen@yahoo.dk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | The Donor Study |
| Study hypothesis | Platelet-rich fibrin shortens wound healing time and improves aesthetic outcome |
| Ethics approval(s) | Yes, 19/09/2005, ref: (KF)01286728 |
| Condition | Chronic leg ulcer |
| Intervention | Split-thickness skin transplantation |
| Intervention type | Other |
| Primary outcome measure | Epithelialization on day five and nine post-operatively |
| Secondary outcome measures | 1. Clinical appearance 2. Histological evaluation 3. Transepidermal Water Loss (TEWL) 4. Erythema 5. Microbiology 6. Incidence of infection 7. Unwanted side effects 8. Temperature difference between treated patients and control group patients |
| Overall study start date | 01/01/2006 |
| Overall study end date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. Patients undergoing surgery for chronic leg ulcer 2. Aged over 18 years 3. Written informed consent, the patient is expected to be able to complete the study 4. Donor site area from 2 x (3 cm x 5 cm) to 2 x (7.6 cm x 15 cm) |
| Participant exclusion criteria | 1. Non-Danish speaking 2. Dementia 3. Pregnant or breastfeeding women 4. Patients treated with 10 mg of steroid or more daily 5. Patients that have received thrombocyte-inhibiting medicine less than four days before surgery 6. Patients not suited for general or spinal anaesthesia 7. Patients whose donor site has been used as a donor site before 8. Patients with skin diseases or pathological changes in the skin, including infection |
| Recruitment start date | 01/01/2006 |
| Recruitment end date | 01/04/2007 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Bispebjerg Hospital
2400 Kobenhavn NV
2400
Denmark
2400
Denmark
Sponsor information
Vivolution A/S (Denmark)
Industry
Industry
Blokken 45
3460 Birkeroed
3460
Denmark
| Phone | +45 (0)4581 1962 |
|---|---|
| info@vivolution.dk | |
| Website | http://www.vivolution.com |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/11/2008 | Yes | No | |
| Results article | results | 01/05/2013 | Yes | No |
