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This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. This data will then hopefully enable a multi-center RCT to generate high level evidence on this matter.
Gaining arterial access in the groin is a very common surgical procedure for vascular surgeons. To reach the femoral artery, invisible lymphatic vessels are often harmed and in turn lymphatic injuries are created. Due to their transparent color and small size, these injuries remain unseen during surgery and are therefore untreated. These small lymphatic injuries can lead to wound complications including lymphoceles, lymphatic fistulas and surgical site infections (SSI) that are associated with higher morbidity and prolonged hospital stay, even mandating re-interventions in some cases.
The investigators hope to reduce wound complication rates by visualizing and directly treating these lymphatic injuries. To be able to detect the injuries, PatentBlau V (E131) will be applied, a blue dye with Swissmedic approval for visualization of lymphatic vessels. Sex differences will be noted and analyzed, gender as a dimension is not relevant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visualization of lymphatic injury | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visualization of lymphatic injury and treatment of injury (in case of detection) | Procedure | PatentBlau V application: 2ml will be injected intradermally around the groin wound. After allowing a maximum of 10 minutes for lymphatic uptake of the blue dye, a thorough inspection of the wound will be performed to detect possible lymphatic injuries, which will be visible by the blue color. Direct treatment (e.g. suture, clipping) of visible lymphatic injuries will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI) | Wound complications defined as follows: Lymphocele: localized fluid collection at the site of surgical dissection; Lymphatic fistula: persistent external drainage of clear fluid for the wound > 72h after surgery; Surgical Site Infection (SSI): according to the CDC definitions. | Up to 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative incidence of lymphatic injury | Intraoperatively | |
| Rate of re-interventions, defined as further invasive measure in the respective groin | Up to 30 days postoperatively | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Giardini, Dr. med. | Contact | +41 61 265 72 22 | matteo.giardini@usb.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000783 | Aneurysm |
| D017541 | Aneurysm, False |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| Lenght of hospital stay |
| Up to 30 days postoperatively |
| 30-day mortality | Up to 30 days postoperatively |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |