NCT06129669

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

October 11, 2023

Last Update Submit

November 7, 2023

Conditions

SurgeryFluorescence

Keywords

Reconstructive surgeryFree flapPedicled flapDebridementFluorescence imagingIndocyanine green

Outcome Measures

Primary Outcomes (3)

  • Maximum perfusion intensity (Normal)

    1\. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame

    Once during the surgery

  • Maximum perfusion intensity (ROI)

    2\. Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame

    Once during the surgery

  • Relative Perfusion

    Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame / Maximum perfusion intensity (Imax, units) in a normal vascularized reference frame

    Once during the surgery

Secondary Outcomes (8)

  • Tmax

    Once during the surgery

  • Ingress

    Once during the surgery

  • Egress

    Once during the surgery

  • Lap Failure

    Follow up at six weeks postoperative

  • Wound infection

    Follow up at six weeks postoperative

  • +3 more secondary outcomes

Study Arms (8)

Debridement after radiotherapy

Debridement after radiotherapy

Drug: Indocyanine green

Debridement after trauma

Debridement after trauma

Drug: Indocyanine green

Reconstructive surgery using a fasciocutaneous flap

Reconstructive surgery using a fasciocutaneous flap

Drug: Indocyanine green

Reconstructive surgery using a muscle flap

Reconstructive surgery using a muscle flap

Drug: Indocyanine green

Reconstructive surgery using a osseous flap

Reconstructive surgery using a osseous flap

Drug: Indocyanine green

Vaginaplasties

Vaginaplasties using a peritoneum flap or colon interposition

Drug: Indocyanine green

Phalloplasties

Phalloplasties

Drug: Indocyanine green

Finger replantation

Finger replantation

Drug: Indocyanine green

Interventions

Indocyanine greenDRUG

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Debridement after radiotherapyDebridement after traumaFinger replantationPhalloplastiesReconstructive surgery using a fasciocutaneous flapReconstructive surgery using a muscle flapReconstructive surgery using a osseous flapVaginaplasties

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

Location

Related Publications (1)

  • Van 't Hof LWP, Koster ITS, Van den Elzen RM, Bouman MB, Botman M, Driessen C. Quantitative Perfusion Assessment Using Indocyanine Green in Lower Extremity Perforator Flaps. Surg Innov. 2025 Oct;32(5):435-441. doi: 10.1177/15533506251339929. Epub 2025 May 19.

    PMID: 40387116DERIVED

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Caroline Driessen

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Plastic Surgeon

Study Record Dates

First Submitted

October 11, 2023

First Posted

November 13, 2023

Study Start

May 9, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

NL(1)