Laser Doppler imaging as a tool in burn wound treatment

ISRCTN	ISRCTN43795467
DOI	https://doi.org/10.1186/ISRCTN43795467
Protocol serial number	Be 2-23
Sponsor	Lithuanian University of Health Sciences (Lithuania)
Funder	Lithuanian University of Health Sciences (Lithuania)

Submission date: 06/09/2012
Registration date: 07/11/2012
Last edited: 07/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Saulius Lukosevicius
Scientific

Lithuanian University of Health Sciences Kaunas Clinics
Department of Radiology
Eiveniu str. 2
Kaunas
LT 50009
Lithuania

Email	saulius.lukosevicius@kaunoklinikos.lt

Study information

Primary study design	Interventional
Study design	Prospective randomized controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Laser Doppler imaging as a tool in burn wound treatment: a prospective randomised trial
Study acronym	LDI
Study objectives	Laser Doppler imaging is the first choice diagnostic approach of burned patients than clinical burn deep examination.
Ethics approval(s)	Kaunas Regional Ethics Committee, 11/04/2009, ref: BE 2-23
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Duration of patients' stay in hospital
Key secondary outcome measure(s)	1. Cost of treatment 2. Sensitivity and specificity of different burn examintion 3. Perfusion parameters of burn tissue during LDI scan
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	70
Key inclusion criteria	1. Burned patients during 72 hours 2. Age 18 to 75 years 3. Agreement to participate in study
Key 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
Date of first enrolment	01/05/2009
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

Lithuania

Study participating centre

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas
LT 50009
Lithuania

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/02/2017: Plain English summary added.