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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03934281
Other study ID # CHMS17001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date February 8, 2021

Study information

Verified date June 2022
Source Centre Hospitalier Metropole Savoie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 8, 2021
Est. primary completion date February 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Honey 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.
HAS 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.

Locations

Country Name City State
France Hélène Blaise Chambéry

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary pain during dressing change: verbal scale of pain 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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