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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
B. Braun Ltd. Centre of Excellence Infection Control
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wounds focused on measuring Acute traumatic wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 29, 2010
Last Updated
April 5, 2012
Sponsor
B. Braun Ltd. Centre of Excellence Infection Control
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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

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

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