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Decision of the Independent Review Committee
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| Name | Class |
|---|---|
| Rangueil Hospital | OTHER |
| University Hospital, Caen | OTHER |
| Beziers Hospital | OTHER |
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Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dressing procedure | Other | One arm receive standard dressing procedure according to the wound |
|
| Flammacerium | Active Comparator | Necrosis covering with Flammacerium 3 mm thick each day during one week then one day on two. On each dressing, remove excess and add flammacerium. Not to remove crust forming until eliminating furrow appears. Cover Flammacerium by compress. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flammacerium | Other |
| ||
| Standard dressing procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Amputation rate | Level of amputation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rate | 6 months | |
| Wound size | 6 months | |
| Pain during dressing (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wound healing Department | Montpellier | 34295 | France |
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|
| 6 months |
| ID | Term |
|---|---|
| C046337 | cerous nitrate, sulfadiazine silver drug combination |
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