The primary objective of this study is the feasibility of assessing the quantified perfusion status of patients with traumatic soft tissue and/or skeletal injuries using NIRF imaging with ICG. Feasibility implies reproducibility of the measurements…
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is an adequate time-intensity curve extracted
from selected regions of interest. Adequate curves are defined as reproducible
curves with accurate representation of the perfusion status. An adequate curve
is characterized by a recognisable in- and outflow pattern representing the
bloodflow in the tissue.
Secondary outcome
As secondary study parameters quantified perfusion parameters will be extracted
from the time-intensity curves. The parameters extracted include:
• Maximum intensity (Imax)
• Time till maximum intensity (Tmax),
• The ingress rate
• The absolute slope
• The normalized slope
• Area under the curve at 30, 60 and 120 seconds
Perfusion parameters will be evaluated for their correlation with:
• Occurrence of necrotic tissue after initial debridement.
• Number of additional debridement procedures after initial debridement due to
the occurrence of necrotic tissue.
• The occurrence of wound infection within 30 days after procedure. Infection
defined as a red, swollen and painful area that is warm and tender to touch,
possibly in combination with fever/chills, purulent effusion, positive cultures
or increased infection parameters.
• The occurrence of a fracture related infection as defined by Metsemakers et
al.14
• Length of hospital stay.
• Number of readmissions within 30 days associated with complications of
primary problem (infection, necrosis, death).
Background summary
In 2020 71.623 Dutch patients were acutely admitted to hospitals due to
sustained traumatic injuries. 7% of the injuries related to open wounds and 44%
to fractures. The majority of traumatic musculoskeletal injuries needs to be
diagnosed and treated as soon as possible to lower the risk of infections and
to minimize adverse outcome, such as necrosis and/or osteomyelitis. To date,
intraoperative assessment of tissue and bone viability is predominantly
subjective, resulting in a variation in thoroughness of debridement. If not all
necrotic tissue is removed, suboptimal healing occurs, which serves as a
potential food source for bacteria. In addition, inadequate initial resection
leads to multiple debridement interventions, leading to prolonged
hospitalization or readmission with consequently high direct medical costs.
Since tissue necrosis is an ongoing process, radical resection of avital tissue
during the initial procedure is not always possible. The surgeon's visual
estimation is not optimal to predict the final amount of debridement. After
maximal debridement, antibiotic treatment and coverage of open wounds, the
incidence of infection can rise to 27%. Compromised perfusion is at the centre
of this problem. An adequate blood supply is crucial for tissue viability and
infection clearance. Near-Infrared Fluorescence (NIRF) imaging with Indocyanine
Green (ICG) has already shown its potential in effective real-time assessment
of intra-operative tissue perfusion and the early prediction of future necrosis
in multiple studies. This technique could potentially be a relevant
contribution in adequately treating soft tissue and skeletal injuries by
creating an improved distinction between viable and non-viable tissue, based on
perfusion indices. However to date, the feasibility to quantify this technique
in posttraumatic tissue has not been successfully evaluated.
Study objective
The primary objective of this study is the feasibility of assessing the
quantified perfusion status of patients with traumatic soft tissue and/or
skeletal injuries using NIRF imaging with ICG. Feasibility implies
reproducibility of the measurements with quantifiable differences in perfusion
patterns that can be correlated to the clinical outcome of adequate and
inadequate perfusion, such as the occurrence of necrosis.
Study design
The study is a prospective observational multicentre pilot study. All included
patients will undergo a perfusion assessment using ICG NIR fluorescence
imaging. Perfusion assessment will not affect treatment of patients.
Study burden and risks
The study will pose no burden and minimal risk for the patients. For the ICG
NIR fluorescence imaging measurement, an intravenous bolus of ICG will be
administered. ICG is a drug approved by the FDA and has been widely used for
assessment of perfusion in other medical fields. ICG has a very low toxicity.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years
• Diagnosed with one or more of the following injuries:
o Crush injury
o Open deglovement
o Open fracture(s) (Gustilo 3, -A, -B & -C)
o Non-union tibia/clavicula/ulna/humerus/rib
o Fracture related infection
• Indication for surgical intervention
Exclusion criteria
• Hemodynamically unstable due to severe blood loss
• Allergic or hypersensitive to iodine/crustaceans/shellfish
• Diagnosed with endocrine thyroid disorders (hypo/hyperthyroidism)
• Pregnancy
• Diagnosed with impaired renal function eGFR <30 L/min/1.73m2
• Diagnosed with severely disturbed hepatic enzymes/liver failure
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84014.058.23 |