Lavasept 2: The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Reduction (log10) in Colony Forming Units [60 minutes]
Comparison of the log10 reduction in CFU after 60 minutes of treatment application.
Secondary Outcome Measures
- Local Tolerability: Pruritis Burning [60 minutes]
Local tolerability after 60 minutes of treatment application.
- Reduction in CFU [15 minutes, 30 minutes and 60 minutes]
Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application
- Comparison of the Percentage of Patients With Target Wounds <50 CFU [60 minutes]
Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application
Eligibility Criteria
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:
-
< 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Zurich | Zurich | Switzerland | 8091 |
Sponsors and Collaborators
- B. Braun Ltd. Centre of Excellence Infection Control
Investigators
- Principal Investigator: Hans Peter Simmen, MD, University of Zurich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OPM-CIC-G-H-0901
Study Results
Participant Flow
| Recruitment Details | Location: Emergency roon in University Hospital |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ringer's Solution | Lavasept 0.04% |
|---|---|---|
| Arm/Group Description | ||
| Period Title: Overall Study | ||
| STARTED | 30 | 30 |
| COMPLETED | 30 | 30 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Ringer's Solution | Lavasept 0.04% | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Participants | 30 | 31 | 61 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
22
73.3%
|
22
71%
|
44
72.1%
|
| >=65 years |
8
26.7%
|
9
29%
|
17
27.9%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
47.63
(24.487)
|
47.68
(23.019)
|
47.66
(23.553)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
23.3%
|
4
12.9%
|
11
18%
|
| Male |
23
76.7%
|
27
87.1%
|
50
82%
|
| Region of Enrollment (participants) [Number] | |||
| Switzerland |
30
100%
|
31
100%
|
61
100%
|
Outcome Measures
| Title | Reduction (log10) in Colony Forming Units |
|---|---|
| Description | Comparison of the log10 reduction in CFU after 60 minutes of treatment application. |
| Time Frame | 60 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: comprising all wounds having received the study treatment for any duration (n=61). |
| Arm/Group Title | Lavasept 0.04% | Ringer's Solution |
|---|---|---|
| Arm/Group Description | Reduction in log 10 Colony Forming Units after 60 minutes of treatment | Reduction in log 10 Colony Forming Units after 60 minutes of treatment |
| Measure Participants | 30 | 30 |
| Measure wounds | 31 | 30 |
| Mean (Standard Deviation) [log 10 Colony Forming Units] |
0.734
(1.00)
|
-0.06
(0.85)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lavasept 0.04%, Ringer's Solution |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.006 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Local Tolerability: Pruritis Burning |
|---|---|
| Description | Local tolerability after 60 minutes of treatment application. |
| Time Frame | 60 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Reduction in CFU |
|---|---|
| Description | Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application |
| Time Frame | 15 minutes, 30 minutes and 60 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Comparison of the Percentage of Patients With Target Wounds <50 CFU |
|---|---|
| Description | Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application |
| Time Frame | 60 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Ringer's Solution | Lavasept 0.04% | ||
| Arm/Group Description | ||||
All Cause Mortality |
||||
| Ringer's Solution | Lavasept 0.04% | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Ringer's Solution | Lavasept 0.04% | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/31 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ringer's Solution | Lavasept 0.04% | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/31 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Medical Affairs Manager |
|---|---|
| Organization | B. Braun Medical, Centre of Excellence |
| Phone | +41 58 258 55 47 |
- OPM-CIC-G-H-0901