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
NCT ID: NCT03934281
Last Updated: 2022-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2018-06-27
2021-02-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HAS dressing
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) .
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.
Honey dressing
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Metropole Savoie
OTHER
Responsible Party
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Locations
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Hélène Blaise
Chambéry, , France
Countries
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Other Identifiers
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CHMS17001
Identifier Type: -
Identifier Source: org_study_id
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