Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.

Study Overview
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Brief Summary
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Wound management is a real public health issue in France. To date, a wide range of devices exists to treat these wounds, depending on their nature and stage of evolution. Honey has been proposed for the care of wounds and is effective in reducing the surface of wounds and the pain perceived by patients. Inanition, its use is very simple compared to usual care, requiring different types of dressing accross time. In the intensive care unit, patients are prone to suffering or developing numerous types of wound, but the interest of honey has not been investigated yet. We propose a prospective, monocentric, randomized, single-blind, controlled clinical trial to assess the efficacy of managing acute cutaneous wounds with honey (Activon®) compared with standard care, in intensive care patients. The primary endpoint is the percentage of wound surface area reduction measured at 15 days from inclusion.

Detailed Description
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Wound management is a real public health issue in France. It affects around 2 million people, and represents a cost of almost 1 billion euros for chronic wounds. Patients in the intensive care unit are prone to suffering or developing numerous types of wound: ulcers, surgical or traumatic wounds on admission or during the stay, pressure sores and wounds associated with medical devices... Several studies have evaluated the use of honey in chronic and acute wounds. It is effective in reducing wound surface area and decreasing pain perceived by patients. A few randomized controlled studies also show faster wound healing, with a significantly greater reduction in surface area, but these mainly concern chronic wounds with long treatment times. Although medical honey is CE-marked for the treatment of acute wounds, no studies have been carried out on the intensive care patient population. The aim of this study is to assess the efficacy of honey (Activon® , Advancis Medical laboratory - DEODAMED, Saint Die des Vosges - France) in the treatment of wounds occurring in intensive care patients, compared with the use of standard devices. Critically ill patients with one or more acute wound (ie <8 days), will be included in absence of known allergy to honey and after consent (by the patient of his/her next of kin if he/she is not able to consent). The wound will be randomized to be treated with honey or standerd care, a maximum of 3 wounds will be randomized by patients. A drawing of the wound will be taken using a layer at inclusion, D7 and D15 (or hospital discharge if it happens first). The area of the wound will be measures by 3 nurses, blinded to the treatment arm, using the formula (A=LengthxWidthxπ/4). The patients will be follow-up at 3 months with a on-site visit to record the date of definitive wound healing.

Official Title
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Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.

Conditions
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Wound Heal, Critical Illness

Intervention / Treatment
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* Device: medical honey Activon® 25g Tube
* Device: standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalization in surgical intensive care unit A -USC PTO CHU ANGERS Informed consent signed by patient or relative (or emergency inclusion procedure) Patient with one or more wounds ≥ 4 cm2, evolving for less than 8 days, including: stage 2, 3, 4 pressure sores, lacerations, ulcers, dermabrasions and scar disunions. Exclusion Criteria: Patients with honey intolerance/allergy to bee stings Patients with wounds lasting more than 8 days Patient with a bleeding wound, Patient with a tunneled wound Patients with chronic dermatoses Patient with an estimated life expectancy < 15 days Expected discharge ≤48 hours. No affiliation to a French social security scheme or beneficiary of such a scheme. Pregnant, breast-feeding or parturient woman Person deprived of liberty by judicial or administrative decision Person subject to a legal protection measure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, parallel arms, single-blinded, single-center study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical honey<br>the patients randomised to this arm will have honey (Activon® Advancis Medical.) | Device: medical honey Activon® 25g Tube<br>* no blinding procedures will be set up for the adminisration of the treatement<br>* Other names: medical honey;|
| Active Comparator: standard of care<br>the patients randomised to this arm will have standard of care recommanded by HAS (french organisation) | Device: standard of care<br>* no blinding procedures will be set up for the adminisration of the treatement<br>* Other names: recommendation of HAS ( french administration);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15). | R = (AJ15-AJ0)/SJ0 x100 with wound area obtained as the mean of the measures made by 3 nurses using a layer of the wound and the formula Area = maximal Length x maximal Width x π/4 R, percentage reduction in surface area (expressed in %); S, surface area (cm²); D, day; D0=day of inclusion | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patient with pain | pain evaluation before and after wound care at Day0,Day7 and Day15, using a numerical scale (graduated from 0 to 10) or the Behavior Pain Scale. A scale >3 or a BPS>6 are indicative of significant pain | Day0, Day7 and Day15 | 
| total healing, | to assess total healing, measured by the proportion of patients with total skin healing at Day7, Day15 (or hospital discharge if before Day15) and Day90 (outpatient visit). | Day0, Day7 and Day15 | 
| scarring progress | To assess scarring progress at Day0, Day7, Day15 and Day90 using a visual colorimetric scale (black = necrosis; yellow = fibrin; red = budding) | Day0, Day7, Day15 and Day90: | 
| Dressing time | To assess the time needed for dressing repair at Day0, Day7 and Day15 (or on day of discharge if before Day15): in minutes | Day0, Day7 and Day15 | 
| numbers of honey tubes used for dressings | to assess Number of honey tubes used for dressings at Day0, Day7 and Day15 (or on day of discharge if before D15). | Day0, Day7 and Day15 | 
| total honey tubes | to asses Number of honey tubes used/returned at Day90 during follow-up visit. | Day90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HONEY