RecruitingNot ApplicableNCT06150326

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


Sponsor

University Hospital, Angers

Enrollment

60 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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

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Interventions

DEVICEmedical honey Activon® 25g Tube

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

DEVICEstandard of care

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


Locations(1)

Angers University Hospital, surgical reanimation

Angers, France

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NCT06150326


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