Wounds
Conditions
Keywords
Acute traumatic wounds
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.
Interventions
DRUGLavasept 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
OTHERRinger'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
Sponsors
B. Braun Ltd. Centre of Excellence Infection Control
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction (log10) in Colony Forming Units | 60 minutes | Comparison of the log10 reduction in CFU after 60 minutes of treatment application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Tolerability: Pruritis Burning | 60 minutes | Local tolerability after 60 minutes of treatment application. |
| Reduction in CFU | 15 minutes, 30 minutes and 60 minutes | Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application |
| Comparison of the Percentage of Patients With Target Wounds <50 CFU | 60 minutes | Comparison of the percentage of patients with target wounds \<50 CFU after 60 minutes of treatment application |
Countries
Switzerland
Participant flow
Recruitment details
Location: Emergency roon in University Hospital
Participants by arm
| Arm | Count |
|---|---|
| Ringer's Solution | 30 |
| Lavasept 0.04% | 31 |
| Total | 61 |
Baseline characteristics
| Characteristic | Lavasept 0.04% | Ringer's Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Age Continuous | 47.68 years STANDARD_DEVIATION 23.019 | 47.63 years STANDARD_DEVIATION 24.487 | 47.66 years STANDARD_DEVIATION 23.553 |
| Region of Enrollment Switzerland | 31 participants | 30 participants | 61 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 27 Participants | 23 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
Primary
Reduction (log10) in Colony Forming Units
Comparison of the log10 reduction in CFU after 60 minutes of treatment application.
Time frame: 60 minutes
Population: ITT population: comprising all wounds having received the study treatment for any duration (n=61).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavasept 0.04% | Reduction (log10) in Colony Forming Units | 0.734 log 10 Colony Forming Units | Standard Deviation 1 |
| Ringer's Solution | Reduction (log10) in Colony Forming Units | -0.06 log 10 Colony Forming Units | Standard Deviation 0.85 |
p-value: =0.006Wilcoxon (Mann-Whitney)
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
Time frame: 60 minutes
Secondary
Local Tolerability: Pruritis Burning
Local tolerability after 60 minutes of treatment application.
Time frame: 60 minutes
Secondary
Reduction in CFU
Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application
Time frame: 15 minutes, 30 minutes and 60 minutes