Lymphatic Injury Visualization in Vascular Surgery

NCT07499206 · tracked via the Priya Life Science Switzerland tracker

Sponsor

University Hospital, Basel, Switzerland

Phase

Not applicable

Started

2026-04

Last updated

2026-03-30

Condition(s) studied

Vascular Surgical ProcedurePeripheral Arterial Disease(PAD)Acute IschemiaHemmorhageAneurysmPseudoaneurysm

Investigational drug(s) / intervention(s)

Visualization of lymphatic injury and treatment of injury (in case of detection)

Visualization 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
University Hospital Basel	Basel	Switzerland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07499206 on ClinicalTrials.gov ↗ ← All trials in Switzerland