Lymphatic Injury Visualization in Vascular Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Hospital, Basel, Switzerland

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Visualization of lymphatic injuryExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 30 days postoperatively

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: