The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds (Lavasept 2)

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.

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Other: Ringer's Solution; Drug: Lavasept 0.04%

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Ringer's Solution	Other: Ringer's Solution; Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound. Dosage Ringers' solution 50ml or as much needed to completely saturate the compress. Treatment Duration 60 minutes
Active Comparator: Lavasept 0.04%	Drug: Lavasept 0.04%; Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound. Dosage Lavasept® 0.04% 50 ml 50ml or as much needed to completely saturate the compress. Treatment Duration 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction (log10) in Colony Forming Units	Comparison of the log10 reduction in CFU after 60 minutes of treatment application.	60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: B. Braun Ltd. Centre of Excellence Infection Control
• Investigators: Principal Investigator: Hans Peter Simmen, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): April 6, 2012
• Last Update Submitted That Met QC Criteria: April 5, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Acute traumatic wounds
• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents; Disinfectants; Polihexanide
• Other Study ID Numbers: OPM-CIC-G-H-0901