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

NCT ID: NCT06150326

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-11
• Study Completion Date: 2026-04-30

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.

Conditions

Wound Heal; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

medical honey

the patients randomised to this arm will have honey (Activon® Advancis Medical.)

Group Type: EXPERIMENTAL

medical honey Activon® 25g Tube

Intervention Type: DEVICE

no blinding procedures will be set up for the adminisration of the treatement

standard of care

the patients randomised to this arm will have standard of care recommanded by HAS (french organisation)

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: DEVICE

no blinding procedures will be set up for the adminisration of the treatement

Interventions

medical honey Activon® 25g Tube

no blinding procedures will be set up for the adminisration of the treatement

Intervention Type: DEVICE

standard of care

no blinding procedures will be set up for the adminisration of the treatement

Intervention Type: DEVICE

Other Intervention Names

medical honey; recommendation of HAS ( french administration)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigismond LASOCKI, MD, PhD

Role: STUDY_CHAIR

anethesia and critical care department, CHU Angers

catherine ROD

Role: PRINCIPAL_INVESTIGATOR

anethesia and critical care department, CHU Angers

Locations

Angers University Hospital, surgical reanimation

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Catherine CR ROD, NURSE

Role: CONTACT

arcdar-angers@chu-angers.fr

0241353635

Sigismond SL LASOCKI, PUPH

Role: CONTACT

silasocki@chu-angers.fr

0241353635

Facility Contacts

Catherine ROD

Role: primary

Catherine.Rod@chu-angers.fr

0241353635

Other Identifiers

2023-A01393-42

Identifier Type: -

Identifier Source: org_study_id