Wound Healing Disturbance of Port-ANCT02072265
Using a Thermal Imaging System to Evaluate the Wound of Port-A and the Relationship Between Thermal Images and Infection
An observational study of Wound Healing Disturbance of Port-A, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Wound Healing Disturbance of Port-A
- What is being tested?
- Infrared thermal images
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving Port-A implantation and removal
Who may be able to join
- clinical requirement of chemotherapy with Port-A
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Po-Yuan Shih, MD, 886-910080024, b87401084@ntu.edu.tw
Po-Yuan Shih, MD
About this study
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
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
- Being tested
- Infrared thermal images
- Keywords
- infrared thermal image, wound healing, wound infection
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared thermal imagesDevice
| Study group | Role | What they receive |
|---|---|---|
| Port-A implantation and chemotherapy | Patients scheduled for Port-A implantation and subsequent chemotherapy Receives: Device: Infrared thermal images | |
| Port-A infection | Patients receiving Port-A removal due to infection Receives: Device: Infrared thermal images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Port-A wound healing/infection status (infrared thermal images)
Measured: 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)
Measured: The patient will be followed once about 6 to 24 hours before the first chemotherapy
Port-A wound healing/infection status (infrared thermal images)
Measured: The patient will be followed once about 6 to 24 hours before the second chemotherapy
Port-A wound healing/infection status (infrared thermal images)
Measured: The patient will be followed once about 1 day before Port-A removal due to infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing Disturbance of Port-AStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072265
- Sponsor's protocol ID
- 201309057RINC
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02072265
- Acronym / sponsor ID
- 201309057RINC
- Conditions
- Wound Healing Disturbance of Port-A
- Keywords
- infrared thermal image, wound healing, wound infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Port-A implantation and chemotherapy | – | Device: Infrared thermal imagesPatients scheduled for Port-A implantation and subsequent chemotherapy |
| Port-A infection | – | Device: Infrared thermal imagesPatients receiving Port-A removal due to infection |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Port-A implantation and removal
Key inclusion criteria (1 listed)
- clinical requirement of chemotherapy with Port-A
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared thermal images | Device | Port-A implantation and chemotherapy, Port-A infection |
Primary outcome
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.
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing Disturbance of Port-A, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Yuan Shih, MD (886-2-23123456 ext. 62158, b87401084@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014; AzTrials last refreshed its copy on 29 Oct 2026.