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

NCT ID: NCT05085509

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Foreign Bodies Ultrasound

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ultrasound

Ultrasound guidance and methylene blue staining

Group Type EXPERIMENTAL

US guidance and MB staining

Intervention Type PROCEDURE

Ultrasound guidance and methylene blue staining

Open surgery

Open surgery without ultrasound guidance and methylene blue staining

Group Type ACTIVE_COMPARATOR

US guidance and MB staining

Intervention Type PROCEDURE

Ultrasound guidance and methylene blue staining

Interventions

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US guidance and MB staining

Ultrasound guidance and methylene blue staining

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Had other injuries
* Presented with more than 3 pieces foreign bodies
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuxi Su

OTHER

Sponsor Role lead

Responsible Party

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Yuxi Su

Orthopaedic Department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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CQMU-20210016

Identifier Type: -

Identifier Source: org_study_id