Lymphatic Injury Visualization in Vascular Surgery

NCT07499206 | Not Yet Recruiting

• 1 other identifier: GCH-008_LymphFistula-Pilot
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease(PAD); Vascular Surgical Procedure; Acute Ischemia; Hemmorhage; Aneurysm; Pseudoaneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (1)

Visualization of lymphatic injury

EXPERIMENTAL

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

Interventions

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.

Visualization of lymphatic injury

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients undergoing vascular surgery procedures in the groin
• signed informed consent for study participation

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Aneurysm; Aneurysm, False

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Matteo Giardini, Dr. med.

CONTACT

+41 61 265 72 22; matteo.giardini@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)