Phase 4 N=60 Randomized Quadruple-blind Prevention

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

Wounds

Bottom Line

View on ClinicalTrials.gov: NCT01153620 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2011

Primary outcome: Primary: Reduction (log10) in Colony Forming Units — 0.734; -0.06 log 10 Colony Forming Units — p==0.006

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lavasept 0.04% (Drug); Ringer's Solution (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: B. Braun Ltd. Centre of Excellence Infection Control
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction (log10) in Colony Forming Units	0.734; -0.06	=0.006 sig
SECONDARY Local Tolerability: Pruritis Burning	—	—
SECONDARY Reduction in CFU	—	—
SECONDARY Comparison of the Percentage of Patients With Target Wounds <50 CFU	—	—

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.

Eligibility 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

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

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Data sourced from ClinicalTrials.gov (NCT01153620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.