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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00371-38 | Other Identifier | ANSM |
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difficulties to recruit patients.
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To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:
This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V.A.C.® Therapy | Experimental | In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers. |
|
| usual dressing method (compresses) | Active Comparator | In this arm, investigators will use the usual dressing method after a transplants of leg ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V.A.C.® | Device | Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of healing between VAC system and compresses for all types of leg ulcers | Number of patients having a wound at least 50% of the grafted area between VAC system and compresses | 1 month after the transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of healing between VAC system and compresses for all types of leg ulcers | Number of patients having a wound at least 50% of the grafted area between VAC system and compresses | 3 months after the transplant |
| Evolution of the pain by Analogic Visual Scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno LABEILLE, MD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de SAINT-ETIENNE | Saint-Etienne | 42000 | France |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| dressing | Device | Patients received usual dressing method (compresses) after a transplants of leg ulcers |
|
Pain score as measured by visual analog scale between VAC system and compresses |
| day 0 : just before the transplant |
| Evolution of the pain by Analogic Visual Scale. | Pain score as measured by visual analog scale between VAC system and compresses | day 1 : the day after the transplant |
| Evolution of the pain by Analogic Visual Scale | Pain score as measured by visual analog scale between VAC system and compresses | Month 1 |
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | day 0 : just before the transplant |
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | Day 5 |
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | Month 1 |
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | Month 3 |
| Cost of the treatment. | Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs | Month 3 |