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

Phase 4

Completed

• Conditions: Wounds
• Interventions: Other: Ringer's Solution; Drug: Lavasept 0.04%

• Registration Number: NCT01153620
• Lead Sponsor: B. Braun Ltd. Centre of Excellence Infection Control

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 wounds.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Study Start: 2010-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-10-21
• Results First Submitted QC: 2011-10-21
• Results First Posted: 2011-11-29
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer's Solution	Ringer's Solution	-
Lavasept 0.04%	Lavasept 0.04%	-

Primary Outcome Measures

Name	Time	Method
Reduction (log10) in Colony Forming Units	60 minutes	Comparison of the log10 reduction in CFU after 60 minutes of treatment application.

Secondary Outcome Measures

Name	Time	Method
Local Tolerability: Pruritis Burning	60 minutes	Local tolerability after 60 minutes of treatment application.
Reduction in CFU	15 minutes, 30 minutes and 60 minutes	Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application
Comparison of the Percentage of Patients With Target Wounds <50 CFU	60 minutes	Comparison of the percentage of patients with target wounds \<50 CFU after 60 minutes of treatment application

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland