Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06150326 |
| Other study ID # |
2023-A01393-42 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
April 2026 |
Study information
| Verified date |
November 2023 |
| Source |
University Hospital, Angers |
| Contact |
Catherine CR ROD, NURSE |
| Phone |
0241353635 |
| Email |
arcdar-angers[@]chu-angers.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
