Trial Outcomes & Findings for The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds (NCT NCT01153620)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

61 participants

Primary outcome timeframe

60 minutes

Results posted on

2012-04-06

Participant Flow

Location: Emergency roon in University Hospital

Participant milestones

Participant milestones
Measure	Ringer's Solution	Lavasept 0.04%
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ringer's Solution n=30 Participants	Lavasept 0.04% n=31 Participants	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age Continuous	47.63 years STANDARD_DEVIATION 24.487 • n=5 Participants	47.68 years STANDARD_DEVIATION 23.019 • n=7 Participants	47.66 years STANDARD_DEVIATION 23.553 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment Switzerland	30 participants n=5 Participants	31 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: ITT population: comprising all wounds having received the study treatment for any duration (n=61).

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

Outcome measures

Outcome measures
Measure	Lavasept 0.04% n=31 wounds Reduction in log 10 Colony Forming Units after 60 minutes of treatment	Ringer's Solution n=30 wounds Reduction in log 10 Colony Forming Units after 60 minutes of treatment
Reduction (log10) in Colony Forming Units	0.734 log 10 Colony Forming Units Standard Deviation 1.00	-0.06 log 10 Colony Forming Units Standard Deviation 0.85

SECONDARY outcome

Timeframe: 60 minutes

Local tolerability after 60 minutes of treatment application.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 minutes, 30 minutes and 60 minutes

Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 minutes

Comparison of the percentage of patients with target wounds \<50 CFU after 60 minutes of treatment application

Outcome measures

Outcome data not reported

Adverse Events

Ringer's Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lavasept 0.04%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Affairs Manager

B. Braun Medical, Centre of Excellence

Phone: +41 58 258 55 47

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60