Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
medical honey Activon® 25g Tube
Deviceno blinding procedures will be set up for the adminisration of the treatement
standard of care
Deviceno blinding procedures will be set up for the adminisration of the treatement
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: medical honeyExperimental treatment 1 intervention
Group B: standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15).
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
Time frame
15 daysSecondary outcomes
1
percentage of patient with pain
pain evaluation before and after wound care at Day0,Day7 and Day15, using a numerical scale (graduated from 0 to 10) or the Behavior Pain Scale. A scale \>3 or a BPS\>6 are indicative of significant pain
Time frame
Day0, Day7 and Day152
total healing,
to assess total healing, measured by the proportion of patients with total skin healing at Day7, Day15 (or hospital discharge if before Day15) and Day90 (outpatient visit).
Time frame
Day0, Day7 and Day153
scarring progress
To assess scarring progress at Day0, Day7, Day15 and Day90 using a visual colorimetric scale (black = necrosis; yellow = fibrin; red = budding)
Time frame
Day0, Day7, Day15 and Day90:4
Dressing time
To assess the time needed for dressing repair at Day0, Day7 and Day15 (or on day of discharge if before Day15): in minutes
Time frame
Day0, Day7 and Day15Sponsors and contacts
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Source ClinicalTrials.gov