Burn prevention trial

JRCT ID: jRCT1051210095

Registered date:01/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation, Atrial flutter, Atrial tachycardia
• Date of first enrollment: 26/10/2021
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Clobetasol propionate 0.05% ointment will be applied immediately after DC and 2 hours later.
Also, the affected area where the defibrillation pad was located in the anterior chest will be cooled with a frozen gel pack wrapped in a towel immediately after DC and for 1 hour.

Outcome(s)

• Primary Outcome: Incidence of grade I degree burns on the anterior chest after 16 hours of DC

Secondary Outcome

(1) Incidence of Grade II burns for each padded area of the anterior and posterior chest after 16 hours of DC, scoring system, CEA, patch test Japanese standard, and area of Grade I and II burns
(2) Incidence of I-degree burns on the padded areas of the back after 16 hours of DC
(3) Burn severity classification and burn severity (scoring system, CEA, Japanese standard for patch test), and area of degree I and II burns for each padded area on the front and back chest after 2 hours of DC
Visual analogue scale (VAS) and facial rating scale (FRS) after 2 hours of DC.
(5) Pain level of the affected area using visual analogue scale (VAS) and facial rating scale (FRS) after 16 hours of DC
(6) Af, AT, and AFL cessation rate
(7) DC frequency
(8) Total energy of DC
(9) Type and dose of anesthetic used

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients aged 20 years or older at the time of consent
(2) Patients who are scheduled to undergo electric cardioversion for atrial fibrillation, atrial tachycardia, or atrial flutter.
(3) Patients for whom written consent has been obtained from the patient.

Exclude criteria

(1) Patients with skin lesions at the site where the defibrillation pad is applied
(2) Patients who are participating in other clinical trials or interventional studies
(3) Patients with a history of hypersensitivity to clobetasol propionate and similar topical steroids
(4) Patients who regularly use concomitantly prohibited drugs.
(5) Patients who have undergone electrical defibrillation with pads on the anterior and posterior chest within the past month.
(6) Patients who are judged by the principal investigator to be inappropriate for participation in this study for other reasons

Related Information

• Primary Sponsor: Kusano Kengo
• Secondary Sponsor: Yamagata Kenichiro