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

Wounds Clinical Trial

— Lavasept 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153620
• Other study ID #: OPM-CIC-G-H-0901
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2010
• Last updated: April 5, 2012
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: B. Braun Ltd. Centre of Excellence Infection Control
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Wounds

Intervention

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

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

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Ltd. Centre of Excellence Infection Control

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction (log10) in Colony Forming Units	Comparison of the log10 reduction in CFU after 60 minutes of treatment application.	60 minutes	No
Secondary	Local Tolerability: Pruritis Burning	Local tolerability after 60 minutes of treatment application.	60 minutes	Yes
Secondary	Reduction in CFU	Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application	15 minutes, 30 minutes and 60 minutes	No
Secondary	Comparison of the Percentage of Patients With Target Wounds <50 CFU	Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application	60 minutes	No