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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210920052524N2
Enrollment
30
Registered
2021-12-01
Start date
2021-11-22
Completion date
Unknown
Last updated
2022-01-11

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

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 fo

Interventions

Intervention 1: Control group: In the control group, the needle is inserted only to a depth of 1 to 2 mm with no injection. Intervention 2: Intervention group: In the intervention group, transplantati

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
The rate of infection is reduced. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: Based on evaluators examination.;Itching. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: By asking patients.;The patient's burning rate decreases. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: By asking patients.;Shock index. Timepoint: The evaluation is performed on 1,6,12 and14 post burn. Method of measurement: It is measured by heartbeat per minute / systolic Blood pressure in mmHg.;SIRS (Systemic inflammatory response syndrome) is reduced. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: It is measured based on body temperature, heart rate, respiratory rate, and WBC number (white blood cells) count.;Cr (creatinine) level. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: Based on patients' laboratory test results.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehryar Habibi Roudkenar

Rasht University of Medical Sciences

Roudkenar@gums.ac.ir+98 13 3336 8540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026