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The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds (Lavasept 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01153620
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : November 29, 2011
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
B. Braun Ltd. Centre of Excellence Infection Control

Study Description
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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
Wounds Drug: Lavasept 0.04% Other: Ringer's Solution Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Reduction (log10) in Colony Forming Units [ Time Frame: 60 minutes ]
    Comparison of the log10 reduction in CFU after 60 minutes of treatment application.


Secondary Outcome Measures :
  1. Local Tolerability: Pruritis Burning [ Time Frame: 60 minutes ]
    Local tolerability after 60 minutes of treatment application.

  2. Reduction in CFU [ Time Frame: 15 minutes, 30 minutes and 60 minutes ]
    Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application

  3. Comparison of the Percentage of Patients With Target Wounds <50 CFU [ Time Frame: 60 minutes ]
    Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153620


Locations
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Switzerland
University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
B. Braun Ltd. Centre of Excellence Infection Control
Investigators
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Principal Investigator: Hans Peter Simmen, MD University of Zurich
More Information
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Responsible Party: B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier: NCT01153620    
Other Study ID Numbers: OPM-CIC-G-H-0901
First Posted: June 30, 2010    Key Record Dates
Results First Posted: November 29, 2011
Last Update Posted: April 6, 2012
Last Verified: April 2012
Keywords provided by B. Braun Ltd. Centre of Excellence Infection Control:
Acute traumatic wounds
Additional relevant MeSH terms:
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Wounds and Injuries
Polihexanide
Disinfectants
Anti-Infective Agents