|
ISRCTN
|
ISRCTN32740751
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Clinical trial on enzymatic agent Salizolis
|
|
Scientific title
|
|
|
Acronym
|
SALIZOLIS
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Lithuania
|
|
Disease/condition/study domain
|
Wounds
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/12/2004
|
|
Anticipated end date
|
31/12/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
30
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
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)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Rimdeika
Rytis
|
|
Address
|
Kaunas Medical University Hospital
Department of Surgery
Division of Plastic Surgery and Burns
Eiveniu str. 2
|
|
City/town
|
Kaunas
|
|
Zip/Postcode
|
50009
|
|
Country
|
Lithuania
|
|
Tel
|
+370 37 326083
|
|
Fax
|
+370 37 326601
|
|
Email
|
rimdeika@kmu.lt
|
|
Sponsor
|
JSC Biocentras (Lithuania)
|
|
Address
|
Graiciuno str. 10
|
|
City/town
|
Vilnius
|
|
Zip/Postcode
|
02241
|
|
Country
|
Lithuania
|
|
Tel
|
+370 5 2661313
|
|
Fax
|
+370 5 2602454
|
|
Email
|
biocentras@biocentras.lt
|
|
Sponsor website:
|
http://www.biocentras.lt/about_en.html
|
|
Date applied
|
09/11/2004
|
|
Last edited
|
03/03/2008
|
|
Date ISRCTN assigned
|
08/12/2004
|
