Clinical trial NCT01434914: Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
Official title: Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ulcus Cruris
Keywords: Ulcus cruris
chronic wounds
octenisept®
Lead sponsor: Schülke & Mayr GmbH
Sponsor class: INDUSTRY
First posted: 2011-09-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.

Detailed description: Randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.

Primary Objectives: Antimicrobial efficacy of octenisept® compared to placebo. Secondary Objectives: Subjective tolerance of octenisept®, evaluation of wound parameters.

Eligibility criteria: Inclusion Criteria:

* Male and female patients of at least 18 years at the time of consent
* Patients with a venous leg ulcer (Ulcus cruris)
* Patients with a chronic leg ulcer
* Females of childbearing potential who are willing to comply with any applicable contraceptive requirements of the protocol
* Negative pregnancy test
* Satisfactory medical assessment
* Ability to provide written informed consent
* Signed declaration of consent
* Willingness to co-operate

Exclusion Criteria:

* Pregnant or lactating women and women not using contraception
* Known history of alcohol or drug abuse
* Use of any antibiotic medication within the last 7 days prior to the first dose
* Patients with serious concomitant disease
* Patients with a coagulation disorder
* Known history of allergic reactions attributed to octenisept® or one of its compounds
* Participation in another clinical trial within the last 30 days before randomization
* Concomitant treatment with other preparations that interfere with the trial preparation or the disease
* Absence of declaration of consent
* Doubt about willingness to co-operate
* Non-fulfilment of the inclusion criteria

Primary outcomes:
measure: Antimicrobial efficacy of octenisept® compared to placebo
timeFrame: 2 weeks after baseline
Secondary outcomes:
measure: Subjective tolerance of octenisept®
timeFrame: 2 weeks after baseline
measure: Evaluation of wound parameters
timeFrame: 2 weeks after baseline
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Matthias Augustin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanscheidt W, Baer M, May TW, Siebert J.: Affecting the wound healing process of chronic ulcera by an octenidine based wound antiseptic. Hyg Med (2005) 30 (5): 153-8
citation: Hubner NO, Siebert J, Kramer A. Octenidine dihydrochloride, a modern antiseptic for skin, mucous membranes and wounds. Skin Pharmacol Physiol. 2010;23(5):244-58. doi: 10.1159/000314699. Epub 2010 May 18.