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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier:
NCT01153620
First received: June 29, 2010
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by B. Braun Ltd. Centre of Excellence Infection Control:

Primary Outcome Measures:
  • Reduction (log10) in Colony Forming Units [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Comparison of the log10 reduction in CFU after 60 minutes of treatment application.


Secondary Outcome Measures:
  • Local Tolerability: Pruritis Burning [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
    Local tolerability after 60 minutes of treatment application.

  • Reduction in CFU [ Time Frame: 15 minutes, 30 minutes and 60 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application


Enrollment: 61
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153620

Locations
Switzerland
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
  More Information

No publications provided

Responsible Party: B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier: NCT01153620     History of Changes
Other Study ID Numbers: OPM-CIC-G-H-0901
Study First Received: June 29, 2010
Results First Received: October 21, 2011
Last Updated: April 5, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by B. Braun Ltd. Centre of Excellence Infection Control:
Acute traumatic wounds

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Polyhexamethylene biguanide
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on June 17, 2013