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| Name | Class |
|---|---|
| Cologne-Merheim Medical Center (CMMC) | UNKNOWN |
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Chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. The sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. The aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. For this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. The wounds are covered with a foam dressing that is changed every 3-4 days. There are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. The primary objective is the reduction of the wound area 14 days and 2 month after intervention. Secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group received a fat grafting under the wound bed and into the wound edges. |
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| Control group | No Intervention | The control group received an injection of saline solution (0.9%) under the wound bed and into the wound edges. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipofilling (sublesional fat grafting) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of wound area | The reduction of the wound area from intervention to 14 days and 2 month post-intervention | 14 days and 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain wound | Subjective pain level of the patient in the area of the wound, measured by the visual analogue scale pre and post intervention | 2 month |
| Bacterial contamination wound | Wound swabs were taken pre intervention and on days 7, 14 and 21 after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver C Thamm, MD, PhD | University of Witten/Herdecke | Principal Investigator |
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Digital analysis of wound area is masked
| 3 weeks |