Laser Doppler imaging as a tool in burn wound treatment
| ISRCTN | ISRCTN43795467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43795467 |
| Secondary identifying numbers | Be 2-23 |
- 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
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
Scientific
Lithuanian University of Health Sciences Kaunas Clinics
Department of Radiology
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
| saulius.lukosevicius@kaunoklinikos.lt |
Study information
| Study design | Prospective randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/05/2009 |
| Completion date | 01/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 70 (35 in each group) |
| 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
LT 50009
Lithuania
Sponsor information
University/education
Department of Radiology
Eiveniu str. 2
Kaunas
LT 50009
Lithuania
| radiologijosklinika@kaunoklinikos.lt | |
| Website | http://www.kmuk.lt/ |
"ROR" |
https://ror.org/0069bkg23 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/02/2017: Plain English summary added.
