The Percentage of Complete Burn Wound Closure Assessment by Indocyanine Green Angiography: A Prospective Multicenter Study

Phase 3

• Conditions: Burn; Indocyanine green; Burns

• Registration Number: TCTR20200222006
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-22
• Study Completion: 2021-02-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion criteria are that patients must be admitted to the hospital with indeterminate burn wounds on any part of the body. They are over 18 years old and are hemodynamically stable (mean arterial pressure ≥ 65 mmHg, urine output of 0.5-1 mL/kg/h, and adequate conscious to understand the study protocol), so they could decide whether to participate to this study or not. Written or fingerprint informed consent is obtained from all participants.

Exclusion Criteria

Exclusion criteria are an allergy to ICG and iodides, pregnancy, bleeding tendency, and psychiatric disorder. Patients are also excluded if they have comorbidities that can alter the wound outcomes, including diabetes mellitus, malnutrition, current active infection, immunocompromised host, obesity, old age (over 65 years old), and anti-inflammatory drug use. Indeterminate wound areas that contained scars, moles, or tattoos are excluded. Participants who are not willing to travel to the 1-month wound assessment are excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the overall percent of wound closures 1 day A 3-dimensional wound measurement device.

Secondary Outcome Measures

Name	Time	Method
the percent of wound closures at one month 1 day A 3-dimensional wound measurement device.