Clinical trial NCT06150326: Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
Official title: Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Wound Heal
Critical Illness
Keywords: HONEY
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, parallel arms, single-blinded, single-center study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15).
timeFrame: 15 days
Secondary outcomes:
measure: percentage of patient with pain
timeFrame: Day0, Day7 and Day15
measure: total healing,
timeFrame: Day0, Day7 and Day15
measure: scarring progress
timeFrame: Day0, Day7, Day15 and Day90:
measure: Dressing time
timeFrame: Day0, Day7 and Day15
measure: numbers of honey tubes used for dressings
timeFrame: Day0, Day7 and Day15
measure: total honey tubes
timeFrame: Day90
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital, surgical reanimation
Study officials:
affiliation: anethesia and critical care department, CHU Angers
name: Sigismond LASOCKI, MD, PhD
role: STUDY_CHAIR
affiliation: anethesia and critical care department, CHU Angers
name: catherine ROD
role: PRINCIPAL_INVESTIGATOR
References: