WoundsPhase 4Lavasept 2NCT01153620
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
A Phase 4 study testing Lavasept 0.04% and Ringer's Solution in people with Wounds, run by B. Braun Ltd. Centre of Excellence Infection Control at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- Lavasept 0.04% and Ringer's Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2010to Jan 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
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
- Being tested
- Lavasept 0.04%, Ringer's Solution
- Keywords
- Acute traumatic wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Ringer's SolutionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ringer's Solution | Placebo comparator | Not described Receives: Other: Ringer's Solution |
| Lavasept 0.04% | Active comparator | Not described Receives: Drug: Lavasept 0.04% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction (log10) in Colony Forming Units
Comparison of the log10 reduction in CFU after 60 minutes of treatment application.
Measured: 60 minutes
Secondary outcomes (3)
Local Tolerability: Pruritis Burning
Local tolerability after 60 minutes of treatment application.
Measured: 60 minutes
Reduction in CFU
Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application
Measured: 15 minutes, 30 minutes and 60 minutes
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
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Peter Simmen, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153620
- Sponsor's protocol ID
- OPM-CIC-G-H-0901
- Acronym
- Lavasept 2
- Status last verified
- Apr 2012
- First submitted
- 29 Jun 2010
- Last updated
- 6 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled Clinical Trial on the Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds
- ClinicalTrials.gov ID
- NCT01153620
- Acronym / sponsor ID
- Lavasept 2 / OPM-CIC-G-H-0901
- Conditions
- Wounds
- Keywords
- Acute traumatic wounds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection ControlIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Posted 29 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer's Solution | Placebo comparator | Other: Ringer's Solution |
| Lavasept 0.04% | Active comparator | Drug: Lavasept 0.04% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Lavasept 0.04% |
| Ringer's SolutionMethod 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 | Other | Ringer's Solution |
Primary outcome
Reduction (log10) in Colony Forming Units
Time frame: 60 minutes
Comparison of the log10 reduction in CFU after 60 minutes of treatment application.
3 secondary outcomes
Local Tolerability: Pruritis Burning
Time frame: 60 minutes
Reduction in CFU
Time frame: 15 minutes, 30 minutes and 60 minutes
Comparison of the Percentage of Patients With Target Wounds <50 CFU
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Peter Simmen, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lavasept 0.04% and Ringer's Solution in people with Wounds, run by B. Braun Ltd. Centre of Excellence Infection Control at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction (log10) in Colony Forming Units (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.