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

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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasound; Foreign Bodies
• Intervention / Treatment: Procedure: US guidance and MB staining

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound; Ultrasound guidance and methylene blue staining	Procedure: US guidance and MB staining; Ultrasound guidance and methylene blue staining
Active Comparator: Open surgery; Open surgery without ultrasound guidance and methylene blue staining	Procedure: US guidance and MB staining; Ultrasound guidance and methylene blue staining

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery time	Time from incision made to incision closure	Surgery end time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	The blood loss of all the surgery time	Surgery end time

Collaborators and Investigators

• Sponsor: Yuxi Su

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies
• Other Study ID Numbers: CQMU-20210016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Foreign body removal with the assistance of ultrasound guidance and methylene blue staining in children

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No