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.
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 Type
OBSERVATIONAL
Enrollment
30
Controlled atmosphere wound healing device
CHU Henri Mondor
Créteil, France
Hôpital La Timone
Marseille, France
Hôpital de la Conception
Marseille, France
Hôpital La Timone
Marseille, France
CHU de Nantes Centre des Brûlés
Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice
Assessment of the global safety of VistaCare® in current medical practice in patients with acute or chronic lower limb wounds through monitoring of concurrent averse events throughout the study duration. This will be assessed through the frequency of occurrence of device-related events, throughout the patient's participation in the trial
Time frame: up to 30 days
Assessment of the global Performance of the VistaCare® device in standard medical practice
Assessment of the global performance of the VistaCare® medical device as compared to its labeled performance in the approved indication (wound healing). This will be assessed through a global clinical assessment by the investigator of the wound improvement condition throughout the study visits, measured in 3 grades ranging from Aggravation (worst assessment), through Static (no improvement) to Improved (best assessment), taking into consideration the wound healing stage and general clinical condition per investigator's assessment.
Time frame: up to 30 days
Assessment of time under VistaCare treatment till secondary treatment decision
Assessment of the time in days till decision to wound coverage, graft, wound dressing, or no further treatment needed and patient discharge. Duration in days from VistaCare treatment initiation to decision-making will be tabulated for each patient.
Time frame: up to 15 days
Wound surface calorimetric assessment of wound status
Description of wound clinical status evolution through photography, wound measurement in mm2 and visual assessment of wound status. This measure is based on the surface in mm2 of the wound components on a standard photography, each wound potentially comprising 3 wound stages surfaces : necrotic (worst), granulation and epithelization (most favorable wound healing stage). Those stages are measured on each visit on a standardized photography of the wound and the wound stage evolution in time is assessed for each patient by an external reviewer. Wound staging for each patient will be analyzed in time throughout patient's participation and presented as graphs.
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Nantes, France
Time frame: 30 days
Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events
Safety assessment of the VistaCare® treatment through adverse events monitoring, with frequency of patients presenting with any adverse event and frequency of each adverse event type, namely non-serious unrelated or device-related event (respectively AE, ADE), serious unrelated event (SAE), serious device-related event (SADE), unanticipated device-related event (UADE), or device deficiency. Tabulation of frequencies in percentages of patient occurrence and number of events per patient will be provided.
Time frame: throughout 30 days
TcPO2 assessment
In a sub-group of up to 10 patients, measure of the trans-cutaneous oxygen pressure (TcPO2) around the wound to assess status and potential correlation with wound status. This measure is expressed in mmHG and the correlation between this measure and the wound healing stage will be statistically assessed to indicate if wound healing may be correlated to the oxygen pressure measure.
Time frame: up to 30 days
Quality of Life assessments
Patient visual analogy scale (VAS) assessments of pain and comfort. Those scales are each graduated from 0 (none) to 10 (maximum pain or discomfort). The evolution in times of such scores will be statistically assessed for each patient.
Time frame: throughout 30 days
Duration of hospitalization
Assessment of the total duration of patient hospitalization in days.
Time frame: throughout 30 days