Wound care medical device designer DTAMedical has announced the inclusion of a first patient in a clinical trial with VistaCare ONE for the treatment of acute and chronic wounds, via a concept of contactless Wound Environment Control (WEC) therapy.
This trial, carried out by the plastic, vascular and orthopaedic surgery departments of La Timone and La Conception Hospitals in Marseille (AP-HM) as well as of Henri Mondor Hospital in Créteil (AP-HP), aims to evaluate the performance and safety of the VistaCare ONE device in routine practice for patients suffering from acute, chronic, traumatic or surgical leg wounds.
VistaCare Open post-market clinical follow-up (PMCF) is a prospective, open-label, multi-centre trial evaluating the performance and safety of the VistaCare ONE wound-healing device. About 30 patients will be included. The primary endpoint will be to measure the device’s performance through the use of descriptive indicators of the healing stages and progress.
The study’s secondary endpoints will assess the decision time by type of treatment — covering procedures (with grafts or skin flaps) or dressing — as well as the number of days of hospitalisation required. The secondary endpoints will also include patients’ quality of life (levels of pain and comfort) as well as the user-friendliness of VistaCare ONE for caregivers.
During a presentation at the medical event Journées Cicatrisations 2019 Professor Casanova said: “The VistaCare therapeutic approach envisioned and developed by DTAMedical, based on controlling the wound’s environmental factors, is a hope for many patients who currently have no suitable treatment. For the first time in wound care, doctors will have control over every key healing stage and factor, for a more effective management of complex wounds.”
By placing the wound in a transparent containment device with sterile properties, the VistaCare technology can enable the control and monitoring of critical healing parameters (oxygen, hygrometry, temperature) and allows for immediate therapeutic reactivity, by maintaining a permanent visual contact with the wound. Closest to the needs of the wound, VistaCare is the only device that makes it possible to direct and control the healing process at all times.
François Dufaÿ, founder and CEO of DTAMedical, said: "We are pleased to announce the inclusion of the first patient in this clinical trial to evaluate the performance and safety of the VistaCare healing device in routine practice.”