The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds (Lavasept 2)

B. Braun

Status and phase

Completed

Phase 4

Conditions

Wounds

Treatments

Other: Ringer's Solution

Drug: Lavasept 0.04%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01153620

OPM-CIC-G-H-0901

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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