About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients undergoing vascular surgery procedures in the groin
signed informed consent for study participation
Disqualifiers
pregnant or lactating women
prior groin surgery
infected surgical site in the groin
necessity for further incisions (e.g. bypass surgery)
Trial design
Single group
Treatments tested in this trial
Visualization of lymphatic injury and treatment of injury (in case of detection)
Procedure/SurgeryPatentBlau 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Intraoperative incidence of lymphatic injury
Rate of re-interventions, defined as further invasive measure in the respective groin
Lenght of hospital stay
30-day mortality
Sponsors and contacts
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