The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

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 wounds.

Inclusion Criteria:

• 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 Criteria:

• < 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