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Completed

NCT Number: NCT01153620

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

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.

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Key information

Conditions

Wounds Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lavasept 0.04%

Drug

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

Ringer's Solution

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

B. Braun Ltd. Centre of Excellence Infection Control

Industry

Registry information

Official study title

Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

Acronym: Lavasept 2

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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