Determining critical thresholds of tissue perfusion using indocyanine green in reconstructive surgery

Determining critical thresholds of tissue perfusion using indocyanine green in reconstructive surgery - ICG in reconstructive surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54423

Enrollment

160

Registered

2023-05-17

Start date

2023-06-20

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

weke delen en bot therapeutische verrichtingen Flap surgery tissue reconstruction

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patient undergoing pedicled or free flap surgery which may be or may not be proceeded by debridement of affected tissue.

Exclusion criteria

Exclusion criteria: Allergy Iodine Allergy shellfish Pregnancy or breastfeeding Epilepsy Kidney failure with eGFR

Design outcomes

Primary

Measure	Time frame
Objective perfusion parameters include: 1. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame 2. Maximum perfusion intensity (Imax, units) in region of interest 3. Relative Perfusion (RP,%, = 1/2)	—

Secondary

Measure	Time frame
1. Lap Failure: Quantified as I 50%, V complete 2. Wound infection defined as none, local wound treatment, antibiotics, or hospitalization. 3. Skin necrosis defined as none, partial thickness, and full thickness. 4. Delayed union after 6 months or non-union after 12 months	—

Countries

Netherlands

Outcome results