Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: medical honey Activon® 25g Tube, standard of care.
- Who it may be relevant to
- Registry conditions: Wound Heal, Critical Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device medical honey Activon® 25g Tube
no blinding procedures will be set up for the adminisration of the treatement - Device standard of care
no blinding procedures will be set up for the adminisration of the treatement
Primary outcome measures
- percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15). [Time frame: 15 days]
Secondary outcome measures (6)
- percentage of patient with pain [Time frame: Day0, Day7 and Day15]
- total healing, [Time frame: Day0, Day7 and Day15]
- scarring progress [Time frame: Day0, Day7, Day15 and Day90:]
- Dressing time [Time frame: Day0, Day7 and Day15]
- numbers of honey tubes used for dressings [Time frame: Day0, Day7 and Day15]
- total honey tubes [Time frame: Day90]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Angers University Hospital, surgical reanimation — Angers
Identifiers
NCT: NCT06150326 · 2023-A01393-42