Condition category
Surgery
Date applied
06/09/2012
Date assigned
07/11/2012
Last edited
07/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.kmuk.lt/

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

Publication citations

Additional files

Editorial Notes

07/02/2017: Plain English summary added.