Acute Ischemia, Aneurysm, Hemmorhage, Peripheral Arterial Disease(PAD), Pseudoaneurysm, Vascular Surgical Procedure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREVisualization of lymphatic injury and treatment of injury (in case of detection)
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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* adult patients undergoing vascular surgery procedures in the groin * signed informed consent for study participation
Exclusion criteria
* pregnant or lactating women * prior groin surgery * infected surgical site in the groin * necessity for further incisions (e.g. bypass surgery) * incapability of judgement or consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI) | Up to 30 days postoperatively | 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. |
Secondary
| Measure | 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 |
| Lenght of hospital stay | Up to 30 days postoperatively |
| 30-day mortality | Up to 30 days postoperatively |
Countries
Switzerland
Contacts
CONTACTMatteo Giardini, Dr. med.
Outcome results
None listed