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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ringer's Solution | Placebo Comparator |
| |
| Lavasept 0.04% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavasept 0.04% | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Peter Simmen, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Zurich | Zurich | Canton of Zurich | 8091 | Switzerland |
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Location: Emergency roon in University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Ringer's Solution | |
| FG001 | Lavasept 0.04% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ringer's Solution | |
| BG001 | Lavasept 0.04% | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction (log10) in Colony Forming Units | Comparison of the log10 reduction in CFU after 60 minutes of treatment application. | ITT population: comprising all wounds having received the study treatment for any duration (n=61). | Posted | Mean | Standard Deviation | log 10 Colony Forming Units | 60 minutes | wounds | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ringer's Solution |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Manager | B. Braun Medical, Centre of Excellence | +41 58 258 55 47 |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077331 | Ringer's Solution |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Ringer's Solution | Other | 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 |
|
| 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 |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| wounds |
|
|
|
| Secondary | Local Tolerability: Pruritis Burning | Local tolerability after 60 minutes of treatment application. | Not Posted | 60 minutes |
| Secondary | Reduction in CFU | Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application | Not Posted | 15 minutes, 30 minutes and 60 minutes |
| Secondary | 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 | Not Posted | 60 minutes |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Lavasept 0.04% | 0 | 31 | 0 | 31 |
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