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Predicting the occurrence of gluteal necrosis with near-infrared spectroscopy in pelvic fracture cases: A multicenter study

Predicting the occurrence of gluteal necrosis with near-infrared spectroscopy in pelvic fracture cases: A multicenter study - Prediction of occurrence of gluteal necrosis in pelvic fracture cases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035209
Enrollment
300
Registered
2018-12-15
Start date
2019-02-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

pelvic fracture

Interventions

The rSO2 of the bilateral gluteal muscles of subjects should be measured with INVOS 5100C (Medtronic). The measurement sites (where the sensors are applied) are the midline regions of both sides at th

Sponsors

Kitasato University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients weighing >=40 kg Those with unstable/severe unstable pelvic fractures (based on the 2008 classification of pelvic injury provided by the Japanese Association for the Surgery of Trauma)

Exclusion criteria

Exclusion criteria: Patients for whom NIRS sensor cannot be applied (because of the presence of cutaneous lesion on the gluteal region, etc.) Those for whom NIRS sensor cannot be applied on the gluteal midline regions due to open pelvic fracture Those with stable pelvic fracture

Design outcomes

Primary

MeasureTime frame
Comparison of rSO2 between the two groups (the groups where TAE is performed and not performed)—

Secondary

MeasureTime frame
Incidence of gluteal necrosis and comparison of rSO2 before and after TAE in gluteal necrosis cases—

Countries

Japan

Contacts

Public ContactTakaaki Maruhashi

Kitasato University School of Medicine Department of Emergency and Critical Care Medicine

tmaruhasi@hotmail.co.jp042-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026