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Hyaluronidase for Enhancement of Tissue Perfusion: A Pilot Study

Hyaluronidase for Enhancement of Tissue Perfusion: A Pilot Study - Pilot Hyaluronidase

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53369
Enrollment
10
Registered
2023-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transposition flaps

Interventions

The procedure will start according to the standard surgical protocol. After preparation of the flap, the flap will be measured and a special camera system will be set up to visualize the tracer. Nex

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who will undergo reconstructive surgery at the LUMC in the period May 2023 to Oct 2023 using a perforator flap.

Exclusion criteria

Exclusion criteria: Exclusion criteria included patients with known hyperthyroidism, autonomic thyroid adenoma, lactation, terminal renal insufficiency, congenital heart defects, congestive heart failure, symptoms of shock or hypersensitivity to indocyanine green, sodium iodide, iodine, hyaluronidase, seafood, bovine proteins and/or gelatin hydrolysate.

Design outcomes

Primary

MeasureTime frame
The primary outcome is tissue perfusion of the perforator flap which is visualized using fluorescence imaging.

Secondary

MeasureTime frame
The color (white/pale/pink/red/black), time of capillary filling, texture (hard/soft), temperature (cold/normal/warm), Doppler sound (absent/poor/normal), flap color and any complications (such as wound infection, necrosis and pain) will be checked

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)