The primary objective is to examine the effect of PRP on the time in days to complete healing.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the effect of PRP on the time in days to complete
healing of the grafted butn wound sites.
Secondary outcome
1. Infection rate of the transplanted burn wounds in comparison with standard
treatment.
2. Pain meassured daily with a VAS scale to complete healing of the paired
grafted burn wound sites.
3. Scar assessment with the POSAS scale in comparsion with standard treatment
after 3, 6 months and one year.
Background summary
Autologous platelet rich plasma (PRP) can be collected into a highly
concentrated formula. When plateletes become activated, growth factors are
released and inititate the body's natural healing response.
Autologous platelet-rich plasma (PRP) contains different growth factors such as
platelet-derived growth factor (PDGF)-BB, transforming growth factor (TGF)-β1,
vascular endothelial growth factor (VEGF), endothelial growth factor (EGF) and
fibroblast growth factor (FGF). Growth factors play a role in wound healing,
wound maturation and scar formation.
In a prospective, single-blind, pilot study autologous platelet gel, hastened
wound closure in acute dermal wounds. In a randomised controlled trial
autologous platelet gel increased the healing rate and shortened the time to
undergo reconstructive plastic surgery in acute trauma wounds. Also in chronic
non-healing wounds PRP is used. For instance two prospective randomised trials
examined the use of autologous platelet-rich plasma in diabetic foot ulcers. In
one trial the percentage healed wounds was higher and the time to healing was
shorter in the platelet-rich plasma gel treated group. In a clinical study 14
patients with deep dermal burns were daily treated with commercially available
basic fibroblastic growth factor (bFGF) and this treatment was compared with
the other side which was treated with moist dressings. Significant better
healing percentages were seen after two and three weeks with bFGF.
Different platelet-concentration preparation systems are now commercialy
available. The Gravitational Platelet Separation System (GPS, Biomet Merck
Biomaterials, Darmstadt, Germany) is a commercialy available technique for the
extraction of PRP. The preparation can be performed in the operating room
during the surgical procedure and takes about 30 minutes. The blood of the
patient (55 cc) is centrifuged to platelet rich plasma.
Study objective
The primary objective is to examine the effect of PRP on the time in days to
complete healing.
Study design
Double-blind intervention study.
Intervention
Two equal wound areas of at least 1% of every patient are treated, one wound
area is treated with PRP and one wound area with only standard treatment.
Study burden and risks
Both treatments that patient can be allocated to are standard treaments. An
increase in woundhealing might be expected and therefore better results in scar
formation.
Vondellaan 13
1942 LE
NL
Vondellaan 13
1942 LE
NL
Listed location countries
Age
Inclusion criteria
1. Adult men and women aged 18 years and older (no upper age limit)
2. A full thickness burn which needs primary or secondary transplantation
3. provision of informed consent by patient
Exclusion criteria
1.Likely problems, in the judgement of the investigators, with maintaining follow-up (e.g.patients with no fixed adress will be excluded)
2. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information in the judgement of the attending physician.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28331.094.09 |