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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmaceutical Solutions
Polyhexamethylene biguanide
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on August 21, 2014