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

NCT ID: NCT01153620

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-01-31

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.

Conditions

Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Ringer's Solution

Group Type: PLACEBO_COMPARATOR

Ringer's Solution

Intervention Type: 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

Lavasept 0.04%

Group Type: ACTIVE_COMPARATOR

Lavasept 0.04%

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Ltd. Centre of Excellence Infection Control

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Peter Simmen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital of Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

OPM-CIC-G-H-0901

Identifier Type: -

Identifier Source: org_study_id