Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/11/2004
Date assigned
08/12/2004
Last edited
03/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.biocentras.lt/about_en.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes