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

NCT06150326 | Recruiting Phase 2

• 1 other identifier: 2023-A01393-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal; Critical Illness

Keywords

HONEY

Outcome Measures

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

  15 days

Secondary Outcomes (6)

• percentage of patient with pain

  Day0, Day7 and Day15

• total healing,

  Day0, Day7 and Day15

• scarring progress

  Day0, Day7, Day15 and Day90:

• Dressing time

  Day0, Day7 and Day15

• numbers of honey tubes used for dressings

  Day0, Day7 and Day15

Study Arms (2)

medical honey

EXPERIMENTAL

the patients randomised to this arm will have honey (Activon® Advancis Medical.)

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)

Device: standard of care

Interventions

medical honey Activon® 25g Tube DEVICE

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

Also known as: medical honey

medical honey

standard of care DEVICE

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

Also known as: recommendation of HAS ( french administration)

standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization in surgical intensive care unit A -USC PTO CHU ANGERS
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital, surgical reanimation

Angers, France

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigismond LASOCKI, MD, PhD

  anethesia and critical care department, CHU Angers

  STUDY CHAIR

• catherine ROD

  anethesia and critical care department, CHU Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine CR ROD, NURSE

CONTACT

0241353635; arcdar-angers@chu-angers.fr

Sigismond SL LASOCKI, PUPH

CONTACT

0241353635; silasocki@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome is the area of the wound, which will be measured by 3 nurses blinded to the study arm, using a layer of the wound.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, parallel arms, single-blinded, single-center study

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 29, 2023
• Study Start: June 11, 2024
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

FR (1)