Burn prevention trial

Maximum burn prevention practice versus conventional care for direct current cardioversion: a randomized trial - Burn prevention trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1051210095

Enrollment

120

Registered

2021-10-01

Start date

2021-10-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation, Atrial flutter, Atrial tachycardia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Incidence of grade I degree burns on the anterior chest after 16 hours of DC	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Contacts

Public ContactKengo Kusano

National Cerebral and Cardioascular Center

kusanokengo@ncvc.go.jp+81-6-6170-1070

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026