Clinical research program

Aim

Acquire knowledge on and evaluate the effects of current and new treatment protocols for patients with burns.

Overview

The Clinical research program is one of the 4 original programs of the ADBC, introduced 5 years ago. The first line of research is Development and evaluation of treatment methods. In order to improve the health outcome of patients with burns and the quality of burn care, we aim to acquire knowledge on and to evaluate the effects of current and new treatment protocols for these patients. In view of the lack of evidence based treatments in burns, there is an urgent need for clinical trials.

The second line of research is Development and evaluation of instruments for outcome assessment and diagnosis. Major improvements in burn care in the 20th century have caused a shift in attention from mortality towards the functional outcome of burns. Furthermore, since public health and interventions are driven by the analysis of appropriate outcomes at the community and clinical levels, measuring functional outcomes is important. To do so, a core set of reliable and valid instruments are necessary. Developing and evaluating instruments for outcome assessment is therefore also an important element of this program.

Development and evaluation of treatment methods

Since the start of the program, four randomised controlled clinical trials have been conducted in the three Dutch burn centres in a multicentre layout. These involve facial burns, application of tissue engineered skin, cultured keratinocytes and skin stretching. All studies have a focus on improvement of quality of healing and have measurable outcome parameters.

Most clinical trials are not only multi centre, but also multidisciplinary. In conjunction with a clinical trail, supplementary research questions are addressed, most often in collaboration with one of the other research programs.

For the next couple of years topics of research will focus on tissue engineering, mechanical tension, rehabilitation and initial assessment and management of burns.

Development and evaluation of instruments for outcome assessment and diagnosis

To describe outcome i.e. the functional consequences of burns the International Classification of Functioning, disabilities and health (ICF) is used as a framework (World Health Organization, Geneva, 2001). Using this dimensional approach in measuring health outcomes emphasizes its multidimensionality, and contributes to more precise linking of treatment to the intended areas of outcome.

Steadily a board set of instruments is becoming available to assess outcome in patients with burns, covering all three ICF domains. Most of these instruments have formerly been the object and/or product of research by the ADBC (or its predecessor).

For the next couple of years topics of research will focus on the development and validation of methods regarding relief of scars, itch, and activity in children.

Regarding diagnosis of burn depth, there is a longstanding interest in the possibilities of laser Doppler. The latest development in this area is our collaboration with the Biomedical Optics group of the University of Twente. Since 2005 this group is developing a high speed laser Doppler perfusion imager, the TOPcam (Twentse Optical Perfusion Camera), based on a CMOS imaging array. The clinical trial with the first prototype was very successful. Further testing with the improved, second prototype, will get underway in the fall of 2009.

 Collaborations

– Laboratory of Infectious diseases, Groningen
– Centre for Rehabilitation, University Medical Centre, Groningen
– Biophysical Engineering, BioMedical Technology Institute, University Twente
– VUmc, Amsterdam
– Dept. Electron Microscopy, Academic Medical Centre, Amsterdam
– Dept. Internal Medicine, Martini Hospital, Groningen
– Uniform Data System for Medical Rehabilitation, Amherst, USA