Acute Non Infected Wounds Clinical Trial
Official title:
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected Wounds.
The investigation is designed as a prospective, open, non-controlled clinical investigation.
Wounds to be treated under this protocol should be acute non-infected wounds or post
surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for
a maximum duration of 3 weeks. All subjects will receive continuous negative pressure
treatment with the new NPWT system with a pressure level of -120 mmHg or according to
clinicians' instruction based on the indication.
10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion
criteria and none of the exclusion criteria and who have signed and dated a written informed
consent.
The subjects will be consecutively allocated to a specific subject identification code. The
primary variable wound healing and granulation tissue formation will be assessed by digital
planimeter, digital photography and visual estimation.
Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and
investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of
wound infections according to clinical routine.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment