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Characterization and evaluation of the safety and effectiveness of human umbilical cord blood serum alginate hydrogel on patients with 2A degree burns.

Characterization and evaluation of the safety and effectiveness of human umbilical cord blood serum alginate hydrogel on patients with 2A degree burns(Phase 1 clinical trial)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221130056672N3
Enrollment
30
Registered
2024-01-10
Start date
2024-03-05
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

2A degree burns. Burn of second degree, body region unspecified

Interventions

Intervention 1: Intervention group: Treated with human cord blood serum alginate hydrogel is placed as a layer with a diameter of 5 mm on the 2A degree burn wound and it is bandaged every other day fo

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Men and women aged 18 to 60 who have 2A degree burns with a burn percentage of less than 15% of the body surface. The dimensions of the burn wound should be 10 x 10 cm. Willingness to participate in research and able to answer questions.

Exclusion criteria

Exclusion criteria: Have underlying diseases and immune system defects such as diabetes, cancer, AIDS, high blood pressure and skin allergies. Before entering the sample into the research, they have used a substance other than drinking water on the wound. A person with symptomatic infection in different parts of the body. Burns in the face and genital area. More than 48 hours have passed from the time of the burn to the time of entering the study. According to the doctor's opinion, the person needs to be hospitalized.

Design outcomes

Primary

MeasureTime frame
Healing time. Timepoint: Measurement of healing time on days 0 (before the intervention), 7 and 14. Method of measurement: Photography with Image J software.

Secondary

MeasureTime frame
The amount of pain. Timepoint: Pain measurement on days 0 (before the start of the intervention), 7 and 14. Method of measurement: questionnaire survey (Patient self-report).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Taghiabadi

Tehran University of Medical Sciences

etaghiabadi@sina.tums.ac.ir+98 21 2665 7438

Outcome results

None listed

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