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

Wound Healing Disturbance of Port-A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02072265
• Other study ID #: 201309057RINC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2014
• Last updated: February 24, 2014
• Start date: March 2014

Study information

• Verified date: February 2014
• Source: National Taiwan University Hospital
• Contact: Po-Yuan Shih, MD
• Phone: 886-2-23123456
• Email: b87401084[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Wound Healing Disturbance of Port-A

Intervention

Device:
• Infrared thermal images

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Port-A wound healing/infection status (infrared thermal images)		The patient will be followed once about 6 to 24 hours before the first chemotherapy	No
Primary	Port-A wound healing/infection status (infrared thermal images)		The patient will be followed once about 6 to 24 hours before the second chemotherapy	No
Primary	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	No