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NCT Number: NCT07499206

Lymphatic Injury Visualization in Vascular Surgery

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.

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Key information

Conditions

Vascular Surgical Procedure Acute Ischemia Aneurysm Aneurysm, False Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Hemmorhage Peripheral Arterial Disease Peripheral Arterial Disease(PAD) Peripheral Vascular Diseases Pseudoaneurysm Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Location contact

Edin Mujagic, Prof. Dr. med.

PRINCIPAL_INVESTIGATOR

Matteo Giardini, Dr. med.

CONTACT

[email protected]

+41 61 265 72 22

Matteo Giardini, Dr. med.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI)

    Time frame: 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 outcomes

  1. Intraoperative incidence of lymphatic injury

    Time frame: Intraoperatively

  2. Rate of re-interventions, defined as further invasive measure in the respective groin

    Time frame: Up to 30 days postoperatively

  3. Lenght of hospital stay

    Time frame: Up to 30 days postoperatively

  4. 30-day mortality

    Time frame: Up to 30 days postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Giardini, Dr. med.

CONTACT

[email protected]

+41 61 265 72 22

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: LymphFistula-P

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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