The use of platelet rich plasma in the treatment of acute burns
| ISRCTN | ISRCTN14946762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14946762 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NL28331.094.09 |
| Sponsor | Red Cross Hospital |
| Funders | Association of Dutch Burn Centers, Biomet Nederland BV, Dordrecht |
- Submission date
- 09/09/2015
- Registration date
- 11/09/2015
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
In recent years, a lot of progress has been made in the treatment of burns. Many, however, still leave disfiguring scars. For particularly severe burns which are very deep, drastic treatment is often needed in which the dead tissue is removed (excision) and healthy skin from elsewhere on the body is transplanted over the top (skin graft). Platelets are blood components vital for clotting and preventing bleeding (coagulation). They contain important substances which are thought to play an important role in wound healing, as well as protecting against bacterial infections (by forming a protective barrier between the wound surface and the blood) and providing pain relief. Platelet rich plasma (PRP) is a part of the blood plasma (the liquid part of the blood) with a high platelet concentration. There have not been many studies looking at the use of PRP in the treatment of wounds, however it has been reported to have beneficial effects in a number of studies. The aim of this study is to find out whether adding PRP to skin graft sites on burn victims can help the healing process and improve the overall appearance of scars (scar quality).
Who can participate?
Adult burn victims admitted to the Dutch burn centre Beverwijk (Netherlands) in need of a skin graft.
What does the study involve?
Before going in to surgery, blood is taken from participants so that activated platelet rich plasma can be prepared. In surgery, two similar wound areas are chosen, and are randomly assigned one of two treatments. One area receives standard care only, and the other receives standard care with the additional application of the activated platelet rich plasma. Five to seven days after the surgery, the two wound areas are inspected so that the growth of new skin over the burn wound can be assessed. Patients are also asked about their level of pain, and the presence of bacteria is also measured. The scar quality is also assessed in the outpatient clinic after 3, 6 and 12 months.
What are the possible benefits and risks of participating?
Possible benefits for participants of the study may include improved healing and scar quality. There are no notable side effects of participating.
Where is the study run from?
Burn Centre Beverwijk (Netherlands)
When is the study starting and how long is it expected to run for?
January 2010 to January 2014
Who is funding the study?
1. Association of Dutch Burn Centers (Netherlands)
2. Biomet Nederland BV, Dordrecht (Netherlands)
Who is the main contact?
Dr Roos Marck
Contact information
Scientific
Burn Centre
Vondellaan 13
Beverwijk
1942 LE
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomized parallel trial |
| Secondary study design | Randomised parallel trial |
| Scientific title | The application of platelet rich plasma in the treatment of deep dermal burns: a randomized, double blind, intra-patient controlled study |
| Study objectives | This study aims to clarify the effect of autologous PRP on take rate and epithelialization rate in the treatment of deep dermal and full thickness burn wounds that require excision and skin transplantation. |
| Ethics approval(s) | Medical Ethical Testing Committee, Alkmaar, The Netherlands, 01/06/2010, ref: NL28331.094.09 |
| Health condition(s) or problem(s) studied | Burn wounds |
| Intervention | In patients with burn wounds, one area is treated with excision of the burn and application of a split skin graft (standard care) and in a comparable area with burn wounds, autologous platelet rich plasma is added to the standard care. |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure(s) |
Take rate (percentage of the graft that appeared to be vital and showed good adherence to the wound bed) and epithelialization rate (percentage of the wound closure by either skin graft or outgrowth from graft or wound edges) of the split skin grafts of area A and B at day 5-7 post surgery, as judged by experienced burn clinicians. |
| Key secondary outcome measure(s) |
1. Pain and itch scores of area A and B after surgery until discharge measured using Visual Analogue Thermometer (VAT) score |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 52 |
| Key inclusion criteria | 1. Aged 18 years and older 2. Admitted at the Dutch burn centre in Beverwijk with a full thickness or deep dermal burn wounds with a surface area of at least 2% total body surface area (TBSA) who needed transplantation with a split skin graft |
| Key exclusion criteria | 1. Likely problems, in the judgment of the investigators, with maintaining follow-up 2. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information in the judgment of the attending physician |
| Date of first enrolment | 03/06/2010 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Beverwijk
1942 LE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Substudy results | 12/01/2019 | 10/10/2023 | Yes | No |
Editorial Notes
10/10/2023: Publication reference added.
