Wound HealMICAREANCT06150326
Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
A study testing medical honey Activon® 25g Tube in people with Wound Heal and Critical Illness, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Critical Illness
- What is being tested?
- medical honey Activon® 25g Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Angers University Hospital, surgical reanimation
Angers
Catherine ROD, 0241353635, Catherine.Rod@chu-angers.fr
About this study
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.
Read the detailed description
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.
- Conditions
- Wound Heal, Critical Illness
- Being tested
- medical honey Activon® 25g Tube, standard of care
- Keywords
- HONEY
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical honey Activon® 25g TubeDevice
Also called medical honey
no blinding procedures will be set up for the adminisration of the treatement
standard of careDevice
Also called recommendation of HAS ( french administration)
no blinding procedures will be set up for the adminisration of the treatement
| Study group | Role | What they receive |
|---|---|---|
| medical honey | Experimental | the patients randomised to this arm will have honey (Activon® Advancis Medical.) Receives: Device: medical honey Activon® 25g Tube |
| standard of care | Active comparator | the patients randomised to this arm will have standard of care recommanded by HAS (french organisation) Receives: Device: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Secondary outcomes (6)
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
Measured: Day0, Day7 and Day15
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).
Measured: Day0, Day7 and Day15
scarring progress
To assess scarring progress at Day0, Day7, Day15 and Day90 using a visual colorimetric scale (black = necrosis; yellow = fibrin; red = budding)
Measured: Day0, Day7, Day15 and Day90:
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
Measured: Day0, Day7 and Day15
numbers of honey tubes used for dressings
to assess Number of honey tubes used for dressings at Day0, Day7 and Day15 (or on day of discharge if before D15).
Measured: Day0, Day7 and Day15
total honey tubes
to asses Number of honey tubes used/returned at Day90 during follow-up visit.
Measured: Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start11 Jun 2024
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel arms, single-blinded, single-center study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sigismond LASOCKI, MD, PhD, Study chair, anethesia and critical care department, CHU Angerscatherine ROD, Principal investigator, anethesia and critical care department, CHU Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150326
- Sponsor's protocol ID
- 2023-A01393-42
- Acronym
- MICAREA
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
- ClinicalTrials.gov ID
- NCT06150326
- Acronym / sponsor ID
- MICAREA / 2023-A01393-42
- Conditions
- Wound Heal, Critical Illness
- Keywords
- HONEY
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel arms, single-blinded, single-center study
| Arm | Type | Receives |
|---|---|---|
| medical honey | Experimental | Device: medical honey Activon® 25g Tubethe patients randomised to this arm will have honey (Activon® Advancis Medical.) |
| standard of care | Active comparator | Device: standard of carethe patients randomised to this arm will have standard of care recommanded by HAS (french organisation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical honey Activon® 25g TubeAlso: medical honeyno blinding procedures will be set up for the adminisration of the treatement | Device | medical honey |
| standard of careAlso: recommendation of HAS ( french administration)no blinding procedures will be set up for the adminisration of the treatement | Device | standard of care |
Primary outcome
percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15).
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
6 secondary outcomes
percentage of patient with pain
Time frame: Day0, Day7 and Day15
total healing,
Time frame: Day0, Day7 and Day15
scarring progress
Time frame: Day0, Day7, Day15 and Day90:
Dressing time
Time frame: Day0, Day7 and Day15
numbers of honey tubes used for dressings
Time frame: Day0, Day7 and Day15
total honey tubes
Time frame: Day90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sigismond LASOCKI, MD, PhD study chair
anethesia and critical care department, CHU Angers
catherine ROD principal investigator
anethesia and critical care department, CHU Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical honey Activon® 25g Tube in people with Wound Heal and Critical Illness, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine CR ROD, NURSE (0241353635, arcdar-angers@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15). (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.