Amputation, Amputation Wound, Diabete Mellitus, Toe (Toes); Wound
Conditions
Brief summary
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
Interventions
DEVICEHoney dressing Melectis G
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.
DEVICEHAS recommendation dressing
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.
Sponsors
Centre Hospitalier Metropole Savoie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetic patients * Patients who have had an amputation of one or more toes within four days prior to inclusion without having the second dressing rehabilitated * Written informed consent.
Exclusion criteria
* Known hypersensitivity to honey, hyaluronic acid, guar gum, pectin and/or zinc oxide. * Insipid Diabètes * patient eligible for a dressing by Vacuum Assisted Closure therapy (VAC therapy) * transmetatarsal amputation * Patient with sutured wound * Patient already included in the study, for a previous amputation for wich the wound has not healed. * Failure to comply with protocol requirements * Person protect by article L1121-5 to L1121-8 of the French Health Public. * Patient include in an other clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epidermization rate at 6 months. | 6 months after amputation | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain during dressing change: verbal scale of pain | inclusion, 1month, 2 months, 3months, 4months, 5 months, 6 months,7months,8months, 8months ,9months 10months, 11months, 12 months after amputation up to cicatrization | verbal scale of pain. this scale measures the pain of patient. the ranges are 0 to 4. |
| average length of wound cicatrization | from date of amputation until the date of the first documented complete cicatrization, assessed up to 12 months | The average length of wound healing in case of complete healing before the end of the study. |
| Epidermization rate at 12 months | 12 months after amputation | 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) |
| Epidermization rate at 1 month | 1 month after amputation | 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) |
| Epidermization rate at 2 months | 1 month after amputation | 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) |
| the satisfaction of professionals for the use of honey dressing | 12 months after amputation or at study completion, whichever came first | 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. |
Countries
France
Outcome results
None listed