Clinical relevance of the antimicrobial resistance testing in the treatment of chronic wounds with antiseptics

Clinical relevance of the antimicrobial resistance testing in the treatment of chronic wounds with antiseptics - AntiSeptic

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003321-29-DE

Enrollment

Registered

2019-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decubitus, acute or chronic wounds (open wounds existing = 14 days)

Interventions

Trade Name: Octenisept Pharmaceutical Form: Cutaneous solution INN or Proposed INN: OCTENIDINE DIHYDROCHLORIDE CAS Number: 70775-75-6 Concentration unit: % percent Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Decubitus OR secondary healing acute and chronic wounds 3. Positively tested wound swab for bacteria (incl. multi-resistant bacteria) 4. Patient is capable of understanding the nature, significance and consequence of the clinical trial 5. Given written consent 6. Women of child bearing potential (WOCBP) who apply appropriate methods of contraception throughout the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Occlusive dressing (e.g. VAC) 2. Pregnant or lactating women 3. Known allergies against investigational products

Design outcomes

Primary

Measure	Time frame
Main Objective: To improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. Currently, resistance testing will only be performed for the treatment with antibiotics.;Secondary Objective: Not applicable.;Primary end point(s): Reduction of bacteria;Timepoint(s) of evaluation of this end point: Screening, Visit 1, Visits each week until discharge or wound healing	—

Measure

Time frame

Main Objective: To improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. Currently, resistance testing will only be performed for the treatment with antibiotics.;Secondary Objective: Not applicable.;Primary end point(s): Reduction of bacteria;Timepoint(s) of evaluation of this end point: Screening, Visit 1, Visits each week until discharge or wound healing

—

Secondary

Measure	Time frame
Secondary end point(s): • Wound related adverse events • Improvement of wound healing (scoring questionnaires) • Correlation of laboratory parameters • Length of hospital stay • Use of antibiotics • Length of bed confinement ;Timepoint(s) of evaluation of this end point: Screening, Visit 1, Visits each week until discharge or wound healing	—

Countries

Germany

Contacts

Public ContactJulia Krieger

3CARE

jukrieger@ukaachen.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026