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| Name | Class |
|---|---|
| Pixacare | INDUSTRY |
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The healing of chronic wounds extends over several months and accounts for 3% of the healthcare budget. Care networks capable of managing chronic wounds are heterogeneous, insufficient, and poorly coordinated across the country.
The key levers identified to reduce the costs of chronic wound care are: reducing the number of consultations, shortening healing time, decreasing the weekly frequency of care, and enabling early management of complications through an alert system.
The Ministry of Health now aims to roll out telemonitoring into mainstream practice and to expand new telemonitoring structures to benefit new patients and new pathologies.
A review of the literature on telemedicine in general reveals numerous indicators confirming the strong potential of telemonitoring for chronic wounds to improve care efficiency.
It would allow specialized remote follow-up without adding workload for caregivers while reducing the number of in-person consultations. This expert oversight could lead to better-adapted treatments, resulting in faster healing and a reduced frequency of care.
Adverse developments and complications could also be detected and managed early through an alert system.
No controlled study using a digital tool with an alert system currently undergoing CE class IIa marking has yet effectively assessed the organizational and medical benefits of such telemonitoring for the management of chronic wounds. This is the objective of this research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Telemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs. The study ends 16 weeks after randomization. |
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| Control group | No Intervention | Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The study ends 16 weeks after randomization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pixacare | Device | elemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol. The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs. |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the superiority of a strategy based on home telemonitoring of patients, compared with a conventional follow-up strategy, in reducing the number of in-person consultations with specialized physicians among patients with chronic wounds | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound-healing kinetics measured as the percentage reduction in wound area from baseline to end of study | 16 weeks | |
| To compare, between the two groups (telemonitoring and conventional follow-up), the weekly frequency of dressing changes | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre GUERRESCHI | Contact | +33 3 20 44 56 59 | pierre.guerreschi@chu-lille.fr |
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Experimental group:
Telemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol.
The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs.
The study ends 16 weeks after randomization.
Control group:
Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol.
The study ends 16 weeks after randomization.
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| To compare, between the two groups (telemonitoring and conventional follow-up), the number of complications (infections, amputations). | 16 weeks |
| To compare, between the two groups (telemonitoring and conventional follow-up), the number and cumulative duration of hospitalizations related to the wound. | 16 weeks |
| Patient satisfaction score measured using a standardized digital satisfaction questionnaire integrated into the telemonitoring application | 16 weeks |