Plain English Summary
Background and study aims
Burns result in long stays in hospital and cause psychological problems. The main treatment of burns is early excision (removal) of injured tissue, which reduces inpatient stay and decreases the costs of treatment. There are many methods to assess burn wounds, but clinical examination of burn is still widely use. The aim of this study is to compare two different methods of examination of burned patients, clinical burn depth examination and Laser Doppler imaging, to estimate the impact of the two methods on length of stay in hospital and the costs of burns treatment.
Who can participate?
Patients age 18 to 75 with burns
What does the study involve?
Patients are randomly allocated to be undergo either clinical burn depth examination or
laser Doppler imaging. Both groups also provide a biopsy (sample) of burned tissue under anaesthetic. The duration of the patients' stay in hospital and the cost of treatment are assessed in both groups.
What are the possible benefits and risks of participating?
Laser Doppler imaging may decrease the inpatient stay in hospital and cost of treatment. Clinical burn depth examination and Laser Doppler imaging are non-invasive investigations. There is a risk of wound bleeding after biopsy.
Where is the study run from?
Lithuanian University of Health Sciences (Lithuania)
When is the study starting and how long is it expected to run for?
May 2009 to May 2013
Who is funding the study?
Lithuanian University of Health Sciences (Lithuania)
Who is the main contact?
Dr Algirda Venclauskiene
algirda.venclauskiene@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Saulius Lukosevicius
ORCID ID
Contact details
Lithuanian University of Health Sciences Kaunas Clinics
Department of Radiology
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
-
saulius.lukosevicius@kaunoklinikos.lt
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Be 2-23
Study information
Scientific title
Laser Doppler imaging as a tool in burn wound treatment: a prospective randomised trial
Acronym
LDI
Study hypothesis
Laser Doppler imaging is the first choice diagnostic approach of burned patients than clinical burn deep examination.
Ethics approval
Kaunas Regional Ethics Committee, 11/04/2009, ref: BE 2-23
Study design
Prospective randomized controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Plastic and reconstructive surgery
Intervention
There are two groups of patients:
1. Clinical burn depth examination group
2. Laser Doppler imaging group
Biopsy of burned tissue of both groups is carried out under local or intravenous anesthesia. LDI scan and CBDE are non invasive investigations
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Duration of patients' stay in hospital
Secondary outcome measures
1. Cost of treatment
2. Sensitivity and specificity of different burn examintion
3. Perfusion parameters of burn tissue during LDI scan
Overall trial start date
01/05/2009
Overall trial end date
01/05/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Burned patients during 72 hours
2. Age 18 to 75 years
3. Agreement to participate in study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70 (35 in each group)
Participant exclusion criteria
1. Age > 75 years
2. Pregnant burned women
3. Mental disease of patients
4. Disagreement to participate in clinical study
5. Burned patients with critical condition of health who were treated in intensive care unite department
Recruitment start date
01/05/2009
Recruitment end date
01/05/2013
Locations
Countries of recruitment
Lithuania
Trial participating centre
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
LT 50009
Lithuania
Sponsor information
Organisation
Lithuanian University of Health Sciences (Lithuania)
Sponsor details
Department of Radiology
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
-
radiologijosklinika@kaunoklinikos.lt
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Lithuanian University of Health Sciences (Lithuania)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary