Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of the Efficacy and Tolerance of Honey-impregnated Dressings Versus Non-impregnated Dressings in the Local Management of Pressure Ulcers: A Randomized Single-blind Trial

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: MELECTIS G
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MELECTIS G<br>In addition to usual care as described for the other arm, patients randomized to this arm will have MELECTIS G added to their wound dressing according to the manufacturer's instructions. Intervention: Usual care Intervention: MELECTIS G | Device: MELECTIS G<br>* The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.<br>|
| Active Comparator: Usual care<br>Patients randomized to this are will receive usual care according the current procedures at the Nîmes University Hospital (ICMD010 concerning pressure sore care and SCMD002 concerning referenced anti-pressure sore dressings). Intervention: Usual care | Device: MELECTIS G<br>* The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.<br>Procedure: Usual care<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | Week 1 | 
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | Week 2 | 
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | Week 4 | 
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | Week 8 | 
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | Week 12 | 
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | At treatment stopping if appropriate (before week 12) | 
| Relative variation (%) in wound surface area |  | Week 1 | 
| Relative variation (%) in wound surface area |  | Week 2 | 
| Relative variation (%) in wound surface area |  | Week 4 | 
| Relative variation (%) in wound surface area |  | Week 8 | 
| Relative variation (%) in wound surface area |  | Week 12 | 
| Relative variation (%) in wound surface area |  | At treatment stopping if appropriate (before week 12) | 
| Relative variation (%) in wound depth |  | Week 1 | 
| Relative variation (%) in wound depth |  | Week 2 | 
| Relative variation (%) in wound depth |  | Week 4 | 
| Relative variation (%) in wound depth |  | Week 8 | 
| Relative variation (%) in wound depth |  | Week 12 | 
| Relative variation (%) in wound depth |  | At treatment stopping if appropriate (before week 12) | 
| Has the wound surface area reduced by at least 40%? yes/no |  | Week 2 | 
| Has the wound surface area reduced by at least 40%? yes/no |  | Week 4 | 
| Has the wound surface area reduced by at least 40%? yes/no |  | Week 8 | 
| Has the wound surface area reduced by at least 40%? yes/no |  | Week 12 | 
| Has the wound surface area reduced by at least 40%? yes/no |  | At treatment stopping if appropriate (before week 12) | 
| Number of bacteria species present in the wound |  | Baseline (Day 0) | 
| Number of bacteria species present in the wound |  | Day 14 | 
| Number of bacteria species present in the wound |  | Day 84 | 
| Diversity (Shannon's H) of bacteria species present in the wound |  | Baseline (Day 0) | 
| Diversity (Shannon's H) of bacteria species present in the wound |  | Day 14 | 
| Diversity (Shannon's H) of bacteria species present in the wound |  | Day 84 | 
| Number of bacteria functional groups present in the wound | Functional groups: commensal, pathogenic, weak pathogenic potential | Baseline (Day 0) | 
| Number of bacteria functional groups present in the wound | Functional groups: commensal, pathogenic, weak pathogenic potential | Day 14 | 
| Number of bacteria functional groups present in the wound | Functional groups: commensal, pathogenic, weak pathogenic potential | Day 84 | 
| Diversity (Shannon's H) of bacteria functional groups present in the wound | Functional groups: commensal, pathogenic, weak pathogenic potential | Baseline (Day 0) | 
| Diversity (Shannon's H) of bacteria functional groups present in the wound | Functional groups: commensal, pathogenic, weak pathogenic potential | Day 14 | 
| Diversity (Shannon's H) of bacteria functional groups present in the wound | Functional groups: commensal, pathogenic, weak pathogenic potential | Day 84 | 
| The number of multiresistant bacteria species present in the wound |  | Baseline (Day 0) | 
| The number of multiresistant bacteria species present in the wound |  | Day 14 | 
| The number of multiresistant bacteria species present in the wound |  | Day 84 | 
| the ratio of the number of commensal over the total number of bacteria species present in the wound |  | Baseline (Day 0) | 
| the ratio of the number of commensal over the total number of bacteria species present in the wound |  | Day 14 | 
| the ratio of the number of commensal over the total number of bacteria species present in the wound |  | Day 84 | 
| the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound |  | Baseline (Day 0) | 
| the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound |  | Day 14 | 
| the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound |  | Day 84 | 
| 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 | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | Baseline (Day 0) | 
| Appearance of the pressure ulcer | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | Week 1 | 
| Appearance of the pressure ulcer | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | Week 2 | 
| Appearance of the pressure ulcer | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | Week 4 | 
| Appearance of the pressure ulcer | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | Week 8 | 
| Appearance of the pressure ulcer | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | Week 12 | 
| Appearance of the pressure ulcer | Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | At treatment stopping if appropriate (before week 12) | 
| Presence/absence of adverse events |  | Week 1 | 
| Presence/absence of adverse events |  | Week 2 | 
| Presence/absence of adverse events |  | Week 4 | 
| Presence/absence of adverse events |  | Week 8 | 
| Presence/absence of adverse events |  | Week 12 | 
| Presence/absence of adverse events |  | At treatment stopping if appropriate (before week 12) | 
| Algo plus scale |  | Baseline (Day 0) | 
| Algo plus scale |  | Week 1 | 
| Algo plus scale |  | Week 2 | 
| Algo plus scale |  | Week 4 | 
| Algo plus scale |  | Week 8 | 
| Algo plus scale |  | Week 12 | 
| Algo plus scale |  | 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 | 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 | 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 | 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 | 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 | 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 | At treatment stopping if appropriate (before week 12) |