Contact information
Type
Scientific
Primary contact
Dr Rimdeika Rytis
ORCID ID
Contact details
Kaunas Medical University Hospital
Department of Surgery
Division of Plastic Surgery and Burns
Eiveniu str. 2
Kaunas
50009
Lithuania
+370 37 326083
rimdeika@kmu.lt
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SALIZOLIS
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Wounds
Intervention
The randomised and controlled, single blind and parallel group study will be carried out on two groups. Each group consists of 15 patients.
Patients of group A are being treated according to the current standards of therapy. The wounds will be self-purged out of necrotic tissues.
Patients of group B are being treated according to the new regimen under investigation - enzymatic agent Salizolis. Necrotic tissue of the wounds will be purged out by enzymatic agent.
Intervention type
Drug
Phase
Not Specified
Drug names
Salizolis
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with acute and chronic wounds containing necrotic tissue (thermal and chemical burns, frostbites, trophic ulcers, injuries of truncal and limb, injuries of wrist and hand, injuries of tarsus and foot, varicosis of lower limbs with ulcers and inflammation, foot ulcers, pressure sores, infections on dermal and hypodermal tissue and other purulent inflammations).
Inclusion criteria:
1. Older than 18 years
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
1. Children under the age of 18
2. Pregnant women
3. Soldiers of active service
4. Incurable patients
5. Patients with mental disorder
6. Patients dependent on drugs and alcohol
7. Subjects incapable of giving consent
8. Subjects disagree with participation in clinical trial
Recruitment start date
01/12/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Lithuania
Trial participating centre
Kaunas Medical University Hospital
Kaunas
50009
Lithuania
Sponsor information
Organisation
JSC Biocentras (Lithuania)
Sponsor details
Graiciuno str. 10
Vilnius
02241
Lithuania
+370 5 2661313
biocentras@biocentras.lt
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
Sixth framework programme horizontal research activities involving small and medium sized enterprises (SMEs) co-operative research project - Ultimate Pressure Dressing System for the Management of Venous Ulcers (European Union)
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
Basic results (scientific)
Publication list