The long-term effect of anti-septic with chlorhexidine on skin bacteria

Long-term effect of chlorhexidine gluconate 4% and Chlorhexidine alcohol 5 mg /ml on growth and recolonisation of bacteria on the skin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002751-38-SE

Enrollment

Registered

2020-12-11

Start date

2021-02-01

Completion date

Unknown

Last updated

2024-04-22

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

Conditions

Cutaneous antibacterial efficacy in healthy volunteers.

Interventions

Pharmaceutical Form: Medicated sponge INN or Proposed INN: NA Other descriptive name: CHLORHEXIDINE DIGLUCONATE SOLUTION Concentration unit: % percent Concentration type: equal Concentration number: 4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Written informed consent * > 20 years of age * Undamaged, healthy skin in treatment zones on both shoulders 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 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: * Current or previous dermatological disease * Known allergy to chlorhexidine * Known allergy to dressings containing polyurethane coating with acrylate adhesives (Tegaderm®) * Current or recently terminated (within 14 days) treatment with antibiotics * Continuous use of corticosteroids (> 5mg/day) * Known immunosuppressive disease or immunocompromising treatment * Employment involving contacts with hospitalized patients * Unable to communicate and understand information in Swedish

Design outcomes

Primary

Measure	Time frame
Main Objective: All objectives in the trial are exploratory. No distinction has been made between main and secondary objectives and endpoints, respectively. The following objectives will be investigated: * Normal variation in cutaneous bacterial colonisation after disinfection using chlorhexidine digluconate/alcohol solution * Are there any differences in cutaneous bacterial colonisation after disinfection using medicated sponge of chlorhexidine digluconate for 1 min or 6 min + chlorhexidine/alcohol solution compared to only using chlorhexidine/alcohol solution? * Does resistance to chlorhexidine occur in identified colonies of bacteria?;Secondary Objective: No secondary objectives have been defined.;Primary end point(s): All objectives in the trial are exploratory. No distinction has been made between main and secondary objectives and endpoints, respectively. The following end points are used in the trial: * Amount of bacterial colonisation. Evaluated on a scale from 0 - 4. 0 = No colonies, 1 = 1-5 colonies, 2 = 6-50 colonies, 3 = > 50 colonies, 4 = impossible to distinguish individual colonies due to overgrowth. * Type of bacterial colonisation. Bacterial speices determination by microscopy, staining techniques and MALDI-TOF * Resistance to chlorhexidine evaluated by identification of QAC genes in isolated colonies using polymerase chain reaction;Timepoint(s) of evaluation of this end point: End points will be evaluated in samples taken from skin 2 and 5 days after treatment with disinfectious agents, respectively.	—

Measure

Time frame

Main Objective: All objectives in the trial are exploratory. No distinction has been made between main and secondary objectives and endpoints, respectively. The following objectives will be investigated: * Normal variation in cutaneous bacterial colonisation after disinfection using chlorhexidine digluconate/alcohol solution * Are there any differences in cutaneous bacterial colonisation after disinfection using medicated sponge of chlorhexidine digluconate for 1 min or 6 min + chlorhexidine/alcohol solution compared to only using chlorhexidine/alcohol solution? * Does resistance to chlorhexidine occur in identified colonies of bacteria?;Secondary Objective: No secondary objectives have been defined.;Primary end point(s): All objectives in the trial are exploratory. No distinction has been made between main and secondary objectives and endpoints, respectively. The following end points are used in the trial: * Amount of bacterial colonisation. Evaluated on a scale from 0 - 4. 0 = No colonies, 1 = 1-5 colonies, 2 = 6-50 colonies, 3 = > 50 colonies, 4 = impossible to distinguish individual colonies due to overgrowth. * Type of bacterial colonisation. Bacterial speices determination by microscopy, staining techniques and MALDI-TOF * Resistance to chlorhexidine evaluated by identification of QAC genes in isolated colonies using polymerase chain reaction;Timepoint(s) of evaluation of this end point: End points will be evaluated in samples taken from skin 2 and 5 days after treatment with disinfectious agents, respectively.

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Secondary

Measure	Time frame
Secondary end point(s): No secondary end points have been defined.;Timepoint(s) of evaluation of this end point: No secondary end points have been defined.	—

Countries

Sweden

Contacts

Public ContactTrial coordinator Ida Markström

Region Östergötland

ida.markstrom@regionostergotland.se00460702327761

Outcome results

None listed

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