Clinical trial NCT06129669: ICG Indocyanine Green in Reconstructive Surgery
Official title: Determining Critical Thresholds of Tissue Perfusion With ICG in Reconstructive Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Surgery
Fluorescence
Keywords: Reconstructive surgery
Free flap
Pedicled flap
Debridement
Fluorescence imaging
Indocyanine green
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We include patients that undergo a surgical debridement and/or reconstruction. Each group consists of twenty patients.

The debridement groups mainly consist of post-oncologic patients who have undergone radiotherapy (1A) and trauma patients (1B).

Reconstructive groups include 2A Fasciocutaneous flaps 2B Osseous flaps 2C Muscle flaps 2D Vaginaplasties 2E Phalloplasties 2F Finger replantations

Brief summary: The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or older
* Undergoing debridement and/or reconstructive surgery included in the aforementioned groups

Exclusion Criteria:

* allergy or hypersensitivity to sodium iodide, iodine, ICG or shellfish
* patients with hyperthyroidism and patients with autonomic thyroid adenoma
* pregnancy or lactation
* epilepsy
* severe liver failure
* renal failure with a GFR \<60.

Primary outcomes:
measure: Maximum perfusion intensity (Normal)
timeFrame: Once during the surgery
measure: Maximum perfusion intensity (ROI)
timeFrame: Once during the surgery
measure: Relative Perfusion
timeFrame: Once during the surgery
Secondary outcomes:
measure: Tmax
timeFrame: Once during the surgery
measure: Ingress
timeFrame: Once during the surgery
measure: Egress
timeFrame: Once during the surgery
measure: Lap Failure
timeFrame: Follow up at six weeks postoperative
measure: Wound infection
timeFrame: Follow up at six weeks postoperative
measure: Skin necrosis
timeFrame: Follow up at six weeks postoperative
measure: Delayed union
timeFrame: Follow up at six and twelve months postoperative
measure: Relative Perfusion before and after tissue transfer
timeFrame: Twice during the surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Caroline Driessen
role: PRINCIPAL_INVESTIGATOR
References: