The main objective of this study is to document the effectiveness of a honey-based medical device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical device will be judged according to the evolution of the surface of the wound at the end of 12 weeks of treatment.
The secondary objectives of this study are to compare the following items between the two arms of the study: A. The evolution of skin microbiota in the wound B. The evolution of the surface and the depth of the wound during follow-up C. The healing process D. Patient and caretaker acceptability
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.
Patients will receive usual care according to the current procedures at the Nîmes University Hospital (ICMD010 concerning pressure sore care and SCMD002 concerning referenced anti-pressure sore dressings).
Centre Mutualiste Neurologique Propara
Montpellier, France
CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
Nîmes, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Time frame: Week 12
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Time frame: Week 1
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Time frame: Week 2
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Time frame: Week 4
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Time frame: Week 8
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Time frame: Week 12
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Time frame: At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound surface area
Time frame: Week 1
Relative variation (%) in wound surface area
Time frame: Week 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Relative variation (%) in wound surface area
Time frame: Week 4
Relative variation (%) in wound surface area
Time frame: Week 8
Relative variation (%) in wound surface area
Time frame: Week 12
Relative variation (%) in wound surface area
Time frame: At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound depth
Time frame: Week 1
Relative variation (%) in wound depth
Time frame: Week 2
Relative variation (%) in wound depth
Time frame: Week 4
Relative variation (%) in wound depth
Time frame: Week 8
Relative variation (%) in wound depth
Time frame: Week 12
Relative variation (%) in wound depth
Time frame: At treatment stopping if appropriate (before week 12)
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 2
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 4
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 8
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 12
Has the wound surface area reduced by at least 40%? yes/no
Time frame: At treatment stopping if appropriate (before week 12)
Number of bacteria species present in the wound
Time frame: Baseline (Day 0)
Number of bacteria species present in the wound
Time frame: Day 14
Number of bacteria species present in the wound
Time frame: Day 84
Diversity (Shannon's H) of bacteria species present in the wound
Time frame: Baseline (Day 0)
Diversity (Shannon's H) of bacteria species present in the wound
Time frame: Day 14
Diversity (Shannon's H) of bacteria species present in the wound
Time frame: Day 84
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Time frame: Baseline (Day 0)
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Time frame: Day 14
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Time frame: Day 84
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Time frame: Baseline (Day 0)
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Time frame: Day 14
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Time frame: Day 84
The number of multiresistant bacteria species present in the wound
Time frame: Baseline (Day 0)
The number of multiresistant bacteria species present in the wound
Time frame: Day 14
The number of multiresistant bacteria species present in the wound
Time frame: Day 84
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time frame: Baseline (Day 0)
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time frame: Day 14
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time frame: Day 84
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Time frame: Baseline (Day 0)
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Time frame: Day 14
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Time frame: Day 84
Wound healing speed (change in cm^2 of surface area per week)
Time frame: 12 weeks (or maximum time span if total healing occurs before 12 weeks)
Is the wound completely healed? yes/no
Time frame: Week 12
The time to healing (days)
Time frame: Week 12
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: Baseline (Day 0)
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: Week 1
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: Week 2
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: Week 4
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: Week 8
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: Week 12
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: At treatment stopping if appropriate (before week 12)
Presence/absence of adverse events
Time frame: Week 1
Presence/absence of adverse events
Time frame: Week 2
Presence/absence of adverse events
Time frame: Week 4
Presence/absence of adverse events
Time frame: Week 8
Presence/absence of adverse events
Time frame: Week 12
Presence/absence of adverse events
Time frame: At treatment stopping if appropriate (before week 12)
Algo plus scale
Time frame: Baseline (Day 0)
Algo plus scale
Time frame: Week 1
Algo plus scale
Time frame: Week 2
Algo plus scale
Time frame: Week 4
Algo plus scale
Time frame: Week 8
Algo plus scale
Time frame: Week 12
Algo plus scale
Time frame: At treatment stopping if appropriate (before week 12)
Acceptability of the dressing by the medical staff
Acceptability of the dressing by the medical staff in relation to each of the following: * Overall satisfaction * Easy installation * Ease of removal * conformability of the dressing to the wound * Pain at dressing change * Adhesion of dressing to the wound
Time frame: Week 1
Acceptability of the dressing by the medical staff
Acceptability of the dressing by the medical staff in relation to each of the following: * Overall satisfaction * Easy installation * Ease of removal * conformability of the dressing to the wound * Pain at dressing change * Adhesion of dressing to the wound
Time frame: Week 2
Acceptability of the dressing by the medical staff
Acceptability of the dressing by the medical staff in relation to each of the following: * Overall satisfaction * Easy installation * Ease of removal * conformability of the dressing to the wound * Pain at dressing change * Adhesion of dressing to the wound
Time frame: Week 4
Acceptability of the dressing by the medical staff
Acceptability of the dressing by the medical staff in relation to each of the following: * Overall satisfaction * Easy installation * Ease of removal * conformability of the dressing to the wound * Pain at dressing change * Adhesion of dressing to the wound
Time frame: Week 8
Acceptability of the dressing by the medical staff
Acceptability of the dressing by the medical staff in relation to each of the following: * Overall satisfaction * Easy installation * Ease of removal * conformability of the dressing to the wound * Pain at dressing change * Adhesion of dressing to the wound
Time frame: Week 12
Acceptability of the dressing by the medical staff
Acceptability of the dressing by the medical staff in relation to each of the following: * Overall satisfaction * Easy installation * Ease of removal * conformability of the dressing to the wound * Pain at dressing change * Adhesion of dressing to the wound
Time frame: At treatment stopping if appropriate (before week 12)