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

NCT01153620 | Completed Phase 4 Results DMC

• 1 other identifier: OPM-CIC-G-H-0901
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

Acute traumatic wounds

Outcome Measures

Primary Outcomes (1)

• Reduction (log10) in Colony Forming Units

  Comparison of the log10 reduction in CFU after 60 minutes of treatment application.

  60 minutes

Secondary Outcomes (3)

• Local Tolerability: Pruritis Burning

  60 minutes

• Reduction in CFU

  15 minutes, 30 minutes and 60 minutes

• Comparison of the Percentage of Patients With Target Wounds <50 CFU

  60 minutes

Study Arms (2)

Ringer's Solution

PLACEBO COMPARATOR

Other: Ringer's Solution

Lavasept 0.04%

ACTIVE COMPARATOR

Drug: Lavasept 0.04%

Interventions

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

Lavasept 0.04%

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

Ringer's Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• B. Braun Ltd. Centre of Excellence Infection Control: lead

Study Sites (1)

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Ringer's Solution

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Affairs Manager
• Organization: B. Braun Medical, Centre of Excellence

+41 58 258 55 47

Study Officials

• Hans Peter Simmen, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 6, 2012
• Results First Posted: November 29, 2011

Record last verified: 2012-04

Locations

CH (1)