Study of Safety and Efficacy of mitochondrial transplantation extracted from platelets on grade 3 degree burn; Clinical trial Phase I and II

Phase 1

Recruiting

• Conditions: Condition 1: burn (3th grade). Condition 2: burn (3th grade). Condition 3: burn (3th grade). Condition 4: burn (3th grade). Condition 5: burn (3th grade). Condition 6: burn (3th grade).; Burn of unspecified degree of unspecified site of lower limb, except ankle and foot; Burn and corrosion of trunk; Burn and corrosion of shoulder and upper limb, except wrist and hand; Burn and corrosion of wrist and hand; Burn and corrosion of lower limb, except ankle and foot; Burn and corrosion of ankle and foot

• Registration Number: IRCT20210920052524N2
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age range should be 18 to 65 years
Acute burns should be occurred less than 24 hours
Percentage of Burn should be 20 to 60.
The patient should be capable to fill out the informed consent.

Exclusion Criteria

The patient should have severe hypertension ( 90/160=BP mmHg).
The Cardiac troponin level should be high.
The patient is pregnant.
There are severe underlying diseases.
The patient has peripheral vascular disease.
The patient has an inhalation injury.
The patient has Burn shock (including decreased cardiac output, increased vascular resistance, hypovolemia, and hypoperfusion following severe burn).
The Patient has Known inflammatory disease.
The patient has undergone off-pump surgery.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ratio of Graft to burn percentage is detected. Timepoint: At the admission. Method of measurement: Measurement based on Wallace criteria.;Total fluid receive. Timepoint: At discharge. Method of measurement: It would be recoded based on patients' files.;Hospital stay. Timepoint: At discharge. Method of measurement: It would be recorded based on patients' files.;Final clinical outcome. Timepoint: At discharge. Method of measurement: It would be detected based on patients' files.