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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01407-40 | Other Identifier | RCB number |
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difficulties to include
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| Name | Class |
|---|---|
| MELIPHARM SAS | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MELECTIS G | Experimental | 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 |
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| Usual care | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MELECTIS G | Device | The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in wound surface area according to the Gilman formula | According to the Gilman formula | Week 12 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Lavigne, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Mutualiste Neurologique Propara | Montpellier | 34090 | France | |||
| CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Usual care | Procedure | 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). |
|
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| At treatment stopping if appropriate (before week 12) |
| Nîmes |
| 30029 |
| France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |