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VistaCare® in the Treatment of Wounds of the Lower Extremity

2019-01-08 10:07:34 | BioPortfolio

Summary

Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.

Description

The study is an open-label, prospective, multicenter, post-CE mark (European Conformity assessment indicating marketing approval in Europe) study to assess the safety and performance of the VistaCare® device in the treatment of wounds. The duration of patient follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following initiation of treatment with the device.

Up to 30 patients will be recruited in the trial. Assessments will include clinical status, wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in a study sub-population, visual analogy scales to assess pain and comfort and adverse events monitoring.

Study Design

Conditions

Wound Heal

Intervention

VistaCare®

Location

CHU Henri Mondor
Créteil
France
94010

Status

Recruiting

Source

DTAMedical SAS

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-01-08T10:07:34-0500

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Medical and Biotech [MESH] Definitions

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.

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Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.

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A disease caused by tetanospasmin, a powerful protein toxin produced by CLOSTRIDIUM TETANI. Tetanus usually occurs after an acute injury, such as a puncture wound or laceration. Generalized tetanus, the most common form, is characterized by tetanic muscular contractions and hyperreflexia. Localized tetanus presents itself as a mild condition with manifestations restricted to muscles near the wound. It may progress to the generalized form.

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