Angers University Hospital, surgical reanimation
Angers, France
Location status: Recruiting
NCT Number: NCT06150326
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Angers, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
no blinding procedures will be set up for the adminisration of the treatement
Other names: medical honey
no blinding procedures will be set up for the adminisration of the treatement
Other names: recommendation of HAS ( french administration)
Time frame: 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
Time frame: Day0, Day7 and Day15
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 Day15
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, Day15 and Day90:
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 and Day15
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 Day15
to assess Number of honey tubes used for dressings at Day0, Day7 and Day15 (or on day of discharge if before D15).
Time frame: Day90
to asses Number of honey tubes used/returned at Day90 during follow-up visit.
Contact information is provided by the study sponsor or research team.
Catherine CR ROD, NURSE
CONTACT
Sigismond SL LASOCKI, PUPH
CONTACT
University Hospital, Angers
Other Gov
Acronym: MICAREA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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