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DracoFoam Infekt - A Non-Interventional PMCF-Study on the Safety and Performance of the Medical Device

DracoFoam Infekt - A Non-Interventional PMCF-Study on the Safety and Performance of the Medical Device - ANTISEPT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021418
Enrollment
80
Registered
2020-04-17
Start date
2020-09-28
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

acute and chronic wounds

Interventions

Group 1: Deployment of the products of the DracoFoam Infekt line according to routine practice
the decision on the treatment has to be made by the treating physician independently of the consideration of the patient for study participation
patients will only be asked to participate in the study once the decision to carry out the therapy using a product of the DracoFoam Infekt line has been made by the treating physician.

Sponsors

Dr. Ausbüttel & Co. GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Indication for treatment by antimicrobial wound therapy - Presence of a signed informed consent form (with patient being able to consent) - Age =18 years - Expected ability of the practitioner to provide the patient with regular care as part of routine medical practice

Exclusion criteria

Exclusion criteria: - Incapacity of the patient to consent - Lack of ability of the patient to report any possibly occurring side effects (e.g. in the presence of severe cognitive deficits) - Presence of a terminal disease with a life expectancy of 250cm2 (It is no prerequisite that patients are treatment naïve, when included into the study).

Design outcomes

Primary

MeasureTime frame
1. number of incidents 2. decrease of wound infection/ decrease of signs of infection 3. improvement of the wound situation

Secondary

MeasureTime frame
1. decrease in pain 2. decrease in wound odour 3. improvement of the appearance of the wound surrounding skin

Countries

Germany

Contacts

Public ContactChristina Pankraz

Dr. Ausbüttel & Co. GmbH

studienkoordination@draco.de02312-8666 850

Outcome results

None listed

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