NCT03934281

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Centre Hospitalier Metropole Savoie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabete Mellitus
• Amputation
• Amputation Wound
• Toe (Toes); Wound

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2018-06-27
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2019-05-01
• Last updated: 2022-06-22

Locations

1 site across 1 country: France