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CompletedNCT05085509Updated Oct 20, 2021

Foreign Body Removal With the Assistance of Ultrasound Guidance and Methylene Blue Staining in Children

An interventional study of US guidance and MB staining in Foreign Bodies and Ultrasound, sponsored by Yuxi Su. Completed at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by Yuxi Su · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
1 Year to 18 Years
Sex
All
01

Study summary

Soft-tissue foreign bodies (FB) are very commonly observed in pediatric emergency departments. Some are metallic and can be diagnosed easily via X-ray radiography, whereas others are radiolucent and are hence less easily diagnosed. Not all FB can be removed effectively, even via open surgery and C-arm guidance. This deficiency may potentially be addressed through the ultrasound (US) skills instrument, which is increasingly popular and is convenient for use in the operation room. In the current study, we evaluated the efficiency of FB removal with the assistance of US and methylene blue (MB) staining.

02

Conditions studied

  • Foreign Bodies
  • Ultrasound

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03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with soft-tissue foreign body
  • Must have complete clinical data

Exclusion criteria

Exclusion Criteria:

  • Had other injuries
  • Presented with more than 3 pieces foreign bodies
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Ultrasound

    Ultrasound guidance and methylene blue staining

    Procedure: US guidance and MB staining

  • Active comparator
    Open surgery

    Open surgery without ultrasound guidance and methylene blue staining

    Procedure: US guidance and MB staining

Interventions

  • ProcedureUS guidance and MB staining

    Ultrasound guidance and methylene blue staining

05

What researchers measure

Primary outcomes

  1. Surgery time

    Time from incision made to incision closure

    Time frame: Surgery end time

Secondary outcomes

  1. Blood loss

    The blood loss of all the surgery time

    Time frame: Surgery end time

06

Study locations

1 site
  • Children's Hospital of Chongqing Medical University
    Chongqing, Chongqing 400014, China
07

References and documents

Individual participant data

Plan to share: Undecided — Foreign body removal with the assistance of ultrasound guidance and methylene blue staining in children

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05085509
Lead sponsor
Yuxi Su
Responsible party
Yuxi Su (Orthopaedic Department, Children's Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Oct 20, 2021
Start date
May 1, 2016
Primary completion
May 1, 2016
Completion
Dec 31, 2020
Last update
Oct 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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