Lymphatic Injury Visualization in Vascular Surgery (LymphFistula-P)

Visualization and Treatment of Lymphatic Injury During Vascular Surgery Procedures in the Groin: A Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aneurysm; Peripheral Arterial Disease(PAD); Hemmorhage; Pseudoaneurysm; Acute Ischemia; Vascular Surgical Procedure
• Intervention / Treatment: Procedure: Visualization of lymphatic injury and treatment of injury (in case of detection)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matteo Giardini, Dr. med.; Phone Number: +41 61 265 72 22; Email: matteo.giardini@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
    • Contact: Matteo Giardini, Dr. med.; Phone Number: +41 61 265 72 22; Email: matteo.giardini@usb.ch
    • Principal Investigator: Edin Mujagic, Prof. Dr. med.
    • Principal Investigator: Matteo Giardini, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Visualization of lymphatic injury

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Aneurysm; Aneurysm, False
• Other Study ID Numbers: GCH-008_LymphFistula-Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No