Using a Thermal Imaging System to Evaluate the Wound of Port-A and the Relationship Between Thermal Images and Infection

February 24, 2014 updated by: National Taiwan University Hospital

Utilization of a Medical Dual-spectrum Infrared Thermal Imaging System to Evaluate the Wound Healing of Permanently Implantable Venous Port (Port-A) and to Investigate the Relationship Between the Thermal Images and Subcutaneous/Bloodstream Infection

Permanently implantable venous ports (Port-A) is very important to patients receiving chemotherapy. It not only provides a reliable route to administrate intravenous drugs, and it also requires minimal care when it is not in use. However, catheter related blood stream infection(CRBSI) is one of the serious complications of Port-A. The diagnosis of CRBSI relies on limited tools, including blood culture or symptoms and signs of active infection. In the stage of CRBSI, Port-A removal is necessary and pose the risk for the patients to re-implant the Port-A. Thus, it is crucial to early detect the infection and give appropriate treatment. Among the pathogens, some pathogens are related to skin contaminants. Before systemic spreading, these pathogens may colonize or cause minor infection subcutaneously. This investigation is to utilize a non-invasive dual spectrum infrared imaging system to evaluate the Port-A wound and to detect the infection.

Aim: 1. To build the database of infra-red thermal images of Port-A wound healing. 2. To investigate the thermal images of skin contamination related CRBSI and to compare with the thermal images of the CRBSI of unknown foci

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving Port-A implantation and removal

Description

Inclusion Criteria:

  • clinical requirement of chemotherapy with Port-A

Exclusion Criteria:

  • not able to maintain posture during acquiring the thermal images
  • with other wounds over the nearby area of the Port-A wound
  • with other severe underlying disease and too weak to mobilize

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Port-A implantation and chemotherapy
Patients scheduled for Port-A implantation and subsequent chemotherapy
Device: Infrared thermal images
Port-A infection
Patients receiving Port-A removal due to infection
Device: Infrared thermal images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Port-A wound healing/infection status (infrared thermal images)
Time Frame: The patient will be followed once about 1 day before stitches removal of the port-A wound.
The patient will be followed once about 1 day before stitches removal of the port-A wound.
Port-A wound healing/infection status (infrared thermal images)
Time Frame: The patient will be followed once about 6 to 24 hours before the first chemotherapy
The patient will be followed once about 6 to 24 hours before the first chemotherapy
Port-A wound healing/infection status (infrared thermal images)
Time Frame: The patient will be followed once about 6 to 24 hours before the second chemotherapy
The patient will be followed once about 6 to 24 hours before the second chemotherapy
Port-A wound healing/infection status (infrared thermal images)
Time Frame: The patient will be followed once about 1 day before Port-A removal due to infection
The patient will be followed once about 1 day before Port-A removal due to infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201309057RINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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