Hyaluronidase for Enhancement of Tissue Perfusion: A Pilot Study
Phase 3
Withdrawn
- Conditions
- Transposition flaps1004704310040795
- Registration Number
- NL-OMON53369
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is tissue perfusion of the perforator flap which is<br /><br>visualized using fluorescence imaging.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The color (white/pale/pink/red/black), time of capillary filling, texture<br /><br>(hard/soft), temperature (cold/normal/warm), Doppler sound<br /><br>(absent/poor/normal), flap color and any complications (such as wound<br /><br>infection, necrosis and pain) will be checked</p><br>