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Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey.
Honey is effective in the management of many infected or uninfected post-surgical wounds.
This study focuses on post surgical wounds after toe amputation in diabetic patients.
The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAS dressing | Active Comparator | Patients included in the "HAS dressing" arm will receive the best available dressing according to the HAS recommendations. HAS is the french National Authority for Health (HAS) . |
|
| Honey dressing | Experimental | the honey used in this study is the Melectis G dressing. This is a combination of thyme honey (99.8%) and hyaluronic acid (0.2%). The patient will benefit from the honey dressing until complete healing and/or until the end of the study (maximum 12 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey dressing Melectis G | Device | The protocol includes rinsing the wound with the saline, gently drying the edge of the wound, applying a thin Mélectis®G film to the entire wound surface and covering with a secondary dressing. Dressings will be rehabilitated based on the evolution of the wound and clinical judgement of the investigator or nurse at home as recommended. |
| Measure | Description | Time Frame |
|---|---|---|
| Epidermization rate at 6 months. | the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume six months after (M6), on the volume of the wound in mm3 at J0. (TM6 = (VD0 - VM6) /VD0) | 6 months after amputation |
| Measure | Description | Time Frame |
|---|---|---|
| Epidermization rate at 12 months | the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 12 months after (M12), on the volume of the wound in mm3 at J0. (T = (VD0 - VM12) /VD0) | 12 months after amputation |
| pain during dressing change: verbal scale of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hélène Blaise | Chambéry | 73011 | France |
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|
| HAS recommendation dressing | Device | Patients included in the standard arm will receive the best available dressing according to the HAS recommendations. Dressings will be rehabilitated based on the evolution of the wound and clinical judgement of the investigator or nurse at home as recommended. |
|
verbal scale of pain. this scale measures the pain of patient. the ranges are 0 to 4. |
| inclusion, 1month, 2 months, 3months, 4months, 5 months, 6 months,7months,8months, 8months ,9months 10months, 11months, 12 months after amputation up to cicatrization |
| average length of wound cicatrization | The average length of wound healing in case of complete healing before the end of the study. | from date of amputation until the date of the first documented complete cicatrization, assessed up to 12 months |
| the satisfaction of professionals for the use of honey dressing | the level of satisfaction of all professionals involved in the rehabilitation of the honey dressing, will be evaluated with a Likert scale.The Likert scale, which falls under our definition of a survey scale, is a 5 point scale that ranges from one extreme attitude to another, like "extremely likely" to "not at all likely." They include a moderate or neutral midpoint. | 12 months after amputation or at study completion, whichever came first |
| Epidermization rate at 1 month | the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 1 month after (M1), on the volume of the wound in mm3 at J0. (T = (VD0 - VM1) /VD0) | 1 month after amputation |
| Epidermization rate at 2 months | the relative difference between the volume of the wound in mm3 during the first rehabilitation of the post-operative dressing (J0) and this volume 2 months after (M2), on the volume of the wound in mm3 at J0. (T = (VD0 - VM2) /VD0) | 1 month after amputation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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