The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds (Lavasept 2)
Primary Purpose
Wounds
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Lavasept 0.04%
Ringer's Solution
Sponsored by
About this trial
This is an interventional prevention trial for Wounds focused on measuring 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:
- < 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
Sites / Locations
- University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Ringer's Solution
Lavasept 0.04%
Arm Description
Outcomes
Primary Outcome Measures
Reduction (log10) in Colony Forming Units
Comparison of the log10 reduction in CFU after 60 minutes of treatment application.
Secondary Outcome Measures
Local Tolerability: Pruritis Burning
Local tolerability after 60 minutes of treatment application.
Reduction in CFU
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
Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application
Full Information
NCT ID
NCT01153620
First Posted
June 29, 2010
Last Updated
April 5, 2012
Sponsor
B. Braun Ltd. Centre of Excellence Infection Control
1. Study Identification
Unique Protocol Identification Number
NCT01153620
Brief Title
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Acronym
Lavasept 2
Official Title
Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Ltd. Centre of Excellence Infection Control
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
Acute traumatic wounds
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ringer's Solution
Arm Type
Placebo Comparator
Arm Title
Lavasept 0.04%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lavasept 0.04%
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Ringer's Solution
Intervention Description
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
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Local Tolerability: Pruritis Burning
Description
Local tolerability after 60 minutes of treatment application.
Time Frame
60 minutes
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
< 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Peter Simmen, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
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