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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

Conditions
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Wounds

Intervention / Treatment
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* Drug: Lavasept 0.04%
* Other: Ringer's Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ringer's Solution<br> | Other: Ringer's Solution<br>* 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<br>|
| Active Comparator: Lavasept 0.04%<br> | Drug: Lavasept 0.04%<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute traumatic wounds