Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries

Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries - IMPACT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53249

Enrollment

120

Registered

2023-03-29

Start date

2024-02-08

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Blood flow in soft tissue and bone Musculoskeletal perfusion

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Contacts

Public ContactJ.R. Vorst

Leids Universitair Medisch Centrum

j.r.van_der_vorst@lumc.nl0715299598

Outcome results