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

NCT02072265 | Unknown

• 1 other identifier: 201309057RINC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wound Healing Disturbance of Port-A

Keywords

infrared thermal image; wound healing; wound infection

Outcome Measures

Primary Outcomes (4)

• Port-A wound healing/infection status (infrared thermal images)

  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)

  The patient will be followed once about 6 to 24 hours before the first chemotherapy

• Port-A wound healing/infection status (infrared thermal images)

  The patient will be followed once about 6 to 24 hours before the second chemotherapy

• Port-A wound healing/infection status (infrared thermal images)

  The patient will be followed once about 1 day before Port-A removal due to infection

Study Arms (2)

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

Interventions

Infrared thermal images DEVICE

Port-A implantation and chemotherapy; Port-A infection

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving Port-A implantation and removal

You may qualify if:

• clinical requirement of chemotherapy with Port-A

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

Po-Yuan Shih, MD

CONTACT

886-2-23123456; b87401084@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 26, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

TW (1)