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

Condition(s) studied

Investigational drug(s) / intervention(s)

medical honey Activon® 25g Tube: no blinding procedures will be set up for the adminisration of the treatement

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

Study 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

Primary outcome measure(s)

• percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15). — 15 days
  R = (AJ15-AJ0)/SJ0 x100 with wound area obtained as the mean of the measures made by 3 nurses using a layer of the wound and the formula Area = maximal Length x maximal Width x π/4 R, percentage reduction in surface area (expressed in %); S, surface area (cm²); D, day; D0=day of inclusion

Trial sites (1)

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