Condition category
Skin and Connective Tissue Diseases
Date applied
09/09/2015
Date assigned
11/09/2015
Last edited
10/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roos Marck

ORCID ID

Contact details

Burn Centre
Vondellaan 13
Beverwijk
1942 LE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL28331.094.09

Study information

Scientific title

The application of platelet rich plasma in the treatment of deep dermal burns: a randomized, double blind, intra-patient controlled study

Acronym

Study hypothesis

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

Medical Ethical Testing Committee, Alkmaar, The Netherlands, 01/06/2010, ref: NL28331.094.09

Study design

Double-blind randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Drug names

Primary outcome measures

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.

Secondary outcome measures

1. Pain and itch scores of area A and B after surgery until discharge measured using Visual Analogue Thermometer (VAT) score
2. Bacterial status of area A and B before surgery and twice weekly until discharge with swabs
3. Scar quality at 3, 6 and 12 months of area A and B measured by the POSAS scar assessment scales, Dermaspectrometer (scar color and pigmentation) and Cutometer (scar elasticity)

Overall trial start date

01/06/2010

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

52

Participant 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

Recruitment start date

03/06/2010

Recruitment end date

01/01/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Burn Centre Beverwijk
Vondellaan 13
Beverwijk
1942 LE
Netherlands

Sponsor information

Organisation

Red Cross Hospital

Sponsor details

Vondellaan 13
Beverwijk
1942 LE
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Association of Dutch Burn Centers

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Biomet Nederland BV, Dordrecht

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will present these results at the upcoming European Burn Association Conference September 18th 2015 in Hannover. Furthermore we would like to submit this paper to a peer-reviewed journal in the Trauma or Burn field.

Intention to publish date

31/12/2015

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes