Status:

TERMINATED

Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing

Lead Sponsor:

BSN Medical GmbH

Conditions:

Wounds and Injuries

Skin Diseases

Eligibility:

All Genders

65+ years

Brief Summary

Although, a huge number of acute wounds is treated successfully every year, Health Care Professionals (HCPs) are facing more and more problems when treating skin damages or surgical incisions: The num...

Eligibility Criteria

Inclusion

  • Men, women or diverse
  • ≥ 65 years of age
  • Patient is mentally and physically able to participate in this study
  • Signed informed consent to participate in this study
  • Fragile skin condition
  • Acute wound (surgical wound or laceration), indicated for treatment with the investigational products for a time period of 7 days

Exclusion

  • Infection of the target wound
  • Alcohol or drug addiction
  • Known sensitivity or allergy to any component of the study product
  • Patients who participate in any other clinical study investigating drugs or medical devices

Key Trial Info

Start Date :

September 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 30 2022

Estimated Enrollment :

47 Patients enrolled

Trial Details

Trial ID

NCT04775316

Start Date

September 1 2021

End Date

November 30 2022

Last Update

December 2 2022

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Practice Degenhardt

Bremen, Germany

2

Klinikum Dortmund

Dortmund, Germany

3

orthoGroup

Hamburg, Germany

Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing | DecenTrialz