Phase 4
Completed N=60
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Source: ClinicalTrials.gov NCT01153620 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Reduction (log10) in Colony Forming Units — 0.734; -0.06 log 10 Colony Forming Units — p==0.006
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.
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 |
— | — |
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
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. Informational only — not medical advice.