Clinical trial NCT02072265: Using a Thermal Imaging System to Evaluate the Wound of Port-A and the Relationship Between Thermal Images and Infection
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound Healing Disturbance of Port-A
Keywords: infrared thermal image
wound healing
wound infection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving Port-A implantation and removal

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


Eligibility criteria: 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

Primary outcomes:
measure: Port-A wound healing/infection status (infrared thermal images)
timeFrame: The patient will be followed once about 1 day before stitches removal of the port-A wound.
measure: Port-A wound healing/infection status (infrared thermal images)
timeFrame: The patient will be followed once about 6 to 24 hours before the first chemotherapy
measure: Port-A wound healing/infection status (infrared thermal images)
timeFrame: The patient will be followed once about 6 to 24 hours before the second chemotherapy
measure: Port-A wound healing/infection status (infrared thermal images)
timeFrame: The patient will be followed once about 1 day before Port-A removal due to infection
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: