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

Phase

2/3

Condition

N/A

Treatment

standard of care

medical honey Activon® 25g Tube

Clinical Study ID

NCT06150326

2023-A01393-42

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

standard of care

2/3

June 11, 2024

April 30, 2026

Study Description

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.

Connect with a study center

Angers University Hospital, surgical reanimation
Angers,
France
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.