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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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 wounds.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Ltd. Centre of Excellence Infection Control
• Treatments: Anti-Infective Agents, Local; Pharmaceutical Solutions; Polihexanide; Polyhexamethylene biguanide

Criteria

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