NCT05085509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

October 6, 2021

Last Update Submit

October 19, 2021

Conditions

Foreign BodiesUltrasound

Outcome Measures

Primary Outcomes (1)

  • Surgery time

    Time from incision made to incision closure

    Surgery end time

Secondary Outcomes (1)

  • Blood loss

    Surgery end time

Study Arms (2)

Ultrasound

EXPERIMENTAL

Ultrasound guidance and methylene blue staining

Procedure: US guidance and MB staining

Open surgery

ACTIVE COMPARATOR

Open surgery without ultrasound guidance and methylene blue staining

Procedure: US guidance and MB staining

Interventions

US guidance and MB stainingPROCEDURE

Ultrasound guidance and methylene blue staining

Open surgeryUltrasound

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location

MeSH Terms

Conditions

Foreign Bodies

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Orthopaedic Department

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 20, 2021

Study Start

May 1, 2016

Primary Completion

May 1, 2016

Study Completion

December 31, 2020

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

CN(1)