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

Plain English Summary

Lay summary under review 2

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 dopler image is the first choice diagnostic approach of burned patients than clinical burn deep examination.

Ethics approval

Kaunas Regional Ethics Committee, 11 April 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

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Plastic and Reconstructive Surgery

Intervention

Two groups of patients:
1. Clinical burn depth examination group
2. Lazer dopler imaging group

Biopsy of burned tissue of both groups 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 – 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