Pressure Ulcer
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEMELECTIS G
The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.
PROCEDUREUsual care
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).
Sponsors
Centre Hospitalier Universitaire de Nīmes
MELIPHARM SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Information provided on the implementation of the study, its objectives, constraints and patient rights * The patient, or his/her legal guardian, must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 12 weeks of follow-up * Presence of one or more pressure ulcers at stages 2, 3 or 4 according to the European Pressure Ulcer Advisory Panel - National Pressure Ulcer Advisory Panel (EPUAP-NPUAP) classification * Wound whose surface is between 1 cm\^2 and 15 cm\^2 * Wound present for more than 6 weeks * Patient whose wound requires a modern dressing (that is to say, a bandage that is neither tulle nor gauze) without bactericidal agents or antibiotics * No antibiotics for at least 7 days prior to inclusion (after inclusion, the patient can be treated with antibiotics if necessary, regardless of the indications)
Exclusion criteria
* Patient participating in or having participated in another interventional study in the previous 3 months or currently in a patient exclusion period determined by a previous study. * Patient under judicial protection * Failure to correctly inform the patient or his/her legal representative * Patient (or his/her legal guardian) refusal to sign the consent * The patient is pregnant, parturient, or breastfeeding * Contraindications (or incompatible combination therapy) for a necessary treatment in this study * Patient with an allergy to honey or propolis * The patient's general condition suggests study exclusion before twelve weeks of follow-up * Antibiotics received within 7 days prior to inclusion * Active neoplastic lesion treated with radiation or chemotherapy * Immunosuppressive therapy or other treatment which, in the judgment of the investigator, may interfere with the healing process * Surgery planned within twelve weeks of inclusion * Stage 1 wound according to the EPUAP-NPUAP classification * Amputation wound * Wound related to a surgical treatment or for which an act of revascularization is envisaged within twelve weeks of inclusion * Malignant wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in wound surface area according to the Gilman formula | Week 12 | According to the Gilman formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative variation (%) in wound surface area | Week 1 | — |
| Relative variation (%) in wound depth | Week 1 | — |
| Has the wound surface area reduced by at least 40%? yes/no | Week 2 | — |
| Number of bacteria species present in the wound | Baseline (Day 0) | — |
| Diversity (Shannon's H) of bacteria species present in the wound | Baseline (Day 0) | — |
| Number of bacteria functional groups present in the wound | Baseline (Day 0) | Functional groups: commensal, pathogenic, weak pathogenic potential |
| Diversity (Shannon's H) of bacteria functional groups present in the wound | Baseline (Day 0) | Functional groups: commensal, pathogenic, weak pathogenic potential |
| The number of multiresistant bacteria species present in the wound | Baseline (Day 0) | — |
| Change in wound surface area according to the Gilman formula | Week 1 | According to the Gilman formula |
| the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound | Baseline (Day 0) | — |
| Wound healing speed (change in cm^2 of surface area per week) | 12 weeks (or maximum time span if total healing occurs before 12 weeks) | — |
| Is the wound completely healed? yes/no | Week 12 | — |
| The time to healing (days) | Week 12 | — |
| Appearance of the pressure ulcer | Baseline (Day 0) | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor |
| Presence/absence of adverse events | Week 1 | — |
| Algo plus scale | Baseline (Day 0) | — |
| Acceptability of the dressing by the medical staff | Week 1 | 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 |
| the ratio of the number of commensal over the total number of bacteria species present in the wound | Baseline (Day 0) | — |
Countries
France
Outcome results
None listed