A Clinical Trial of Photoacoustic Imaging in the Planning of Free Flaps

JRCT ID: jRCTs052200139

Registered date:19/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: conditions requiring reconsructive surgeries using free flaps
• Date of first enrollment: 18/08/2021
• Target sample size: 54
• Study type: Interventional
• Intervention(s): The use of photoacoustic imaging in the planning of free flaps

Outcome(s)

Primary Outcome

Subjective evaluation (visibility and ease of use of vascular map)
Objective evaluation (accuracy of the location of perforators)

Secondary Outcome

Visual properties of perforating vessels
Anatomical variations of vessels
Correspondence of findings from photoacoustic imaging and those in ICG tests during surgery

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who are planned to undergo reconstructive surgeries using flaps at Kyoto Univ.'s Hospital
2. Aged 20 years or older at the time of the informed consent

Exclude criteria

1. Pregnant or lactating women
2. Photosensitizer for photodynamic therapy
3. A cardiac pacemaker in their body
4. Severe systemic disease corresponding to ASA-PS (American Society of Anesthesiologists physical status classification) Class 4 or larger.
5. Infection at the examined body sites
6. Difficult in communicating or body positioning during examinations

Related Information

• Primary Sponsor: Saito Susumu
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development