Status:
COMPLETED
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Lead Sponsor:
B. Braun Ltd. Centre of Excellence Infection Control
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic ...
Eligibility Criteria
Inclusion
- Patients with acute traumatic cut, crush, abrasion, bite or stab wounds Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations
- Wounds that are a minimum of approximately 4 cm2 in size
- Ability to read and understand the German patient information sheet and informed consent form
Exclusion
- \< 18 years of age
- Pregnancy
- Immunosuppression
- Wounds caused by a burn
- Wounds that require treatment of hyaline cartilage, the central nervous system, peritoneum, meningae, inner / middle ear or inner eye
- Simultaneous participation in another clinical trial
- Wounds that require immediate surgical or medical treatment as well patients who are critically ill
- Patient with a known allergy to the active agent or any of the excipients
- Wounds that are \>3 cm in depth
- Wounds that have not received medical treatment for ≥6 hours
- Heavily bleeding wounds
- Open fractures, joints or tendons
- Wounds of the face
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01153620
Start Date
August 1 2010
End Date
January 1 2011
Last Update
April 6 2012
Active Locations (1)
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1
University Hospital of Zurich
Zurich, Canton of Zurich, Switzerland, 8091