NCT06150326 Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
| NCT ID | NCT06150326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Wound Heal |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-11 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-06-11 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sigismond LASOCKI, MD, PhD
STUDY CHAIR
anethesia and critical care department, CHU Angers
Frequently Asked Questions
Who can join the NCT06150326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wound Heal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06150326 currently recruiting?
Yes, NCT06150326 is actively recruiting participants. Contact the research team at arcdar-angers@chu-angers.fr for enrollment information.
Where is the NCT06150326 trial being conducted?
This trial is being conducted at Angers, France.
Who is sponsoring the NCT06150326 clinical trial?
NCT06150326 is sponsored by University Hospital, Angers. The principal investigator is Sigismond LASOCKI, MD, PhD at anethesia and critical care department, CHU Angers. The trial plans to enroll 60 participants.