Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

Amputation Clinical Trial

— MELIDIAB  

Official title:

Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934281
• Other study ID #: CHMS17001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amputation
• Amputation Wound
• Diabete Mellitus
• Diabetes Mellitus
• Toe (Toes); Wound
• Wounds and Injuries

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