Status:

TERMINATED

Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Lead Sponsor:

Fredrik Iredahl

Collaborating Sponsors:

Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden

Conditions:

Exuding Wounds

Ulcer, Leg

Eligibility:

All Genders

18+ years

Brief Summary

Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.

Detailed Description

The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds. Using DryMax Sensor and the display indication - advisory only - might i...

Eligibility Criteria

Inclusion

  • male or female, ≥18 years
  • presence of an exuding wound, according to the clinician's assessment
  • the wound is deemed suitable for treatment with DryMax Sensor
  • an appropriate dressing size is available to be used according to the size of the wound
  • the participant has given a written informed consent to participate in the study.

Exclusion

  • known pregnancy at the inclusion visit
  • known or suspected hypersensitivity to the DryMax Sensor or its components
  • mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study
  • ongoing treatment with systemic antibiotics
  • illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study, and/or the dressing.

Key Trial Info

Start Date :

May 21 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 22 2022

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT04890769

Start Date

May 21 2021

End Date

February 22 2022

Last Update

March 18 2022

Active Locations (1)

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1

Primary Health Care Center in Österlötland

Linköping, Sweden