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Treatment of second-degree burn wounds using human placental tissue

Clinical trial of the human acellular placental scaffold for treatment of superficial and deep second-degree burn wounds

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230429058021N2
Enrollment
10
Registered
2025-02-02
Start date
2025-02-17
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Superficial and deep second-degree burn wounds. Burn of second degree of trunk

Interventions

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with superficial and deep second-degree burns with a burn area of ??at least 1%

Exclusion criteria

Exclusion criteria: Cases such as having severe vascular lesions, active or latent infection, or uncontrolled infection at the wound site can prevent the effectiveness of this allograft. Wound dressing derived placenta should not be used to treat lesions that do not have a definitive diagnosis. In patients with metabolic, heart, kidney, liver, blood, autoimmune or any other major diseases, this product should not be used without the permission of the attending physician.

Design outcomes

Primary

MeasureTime frame
Time and size (area) of the wound according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Observation and measurement of wound area.;Redness. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Observation and examination of the patient by a specialist doctor.;Pain level according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Examination of the patient by a specialist doctor.;Check the fever according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Thermometer.

Secondary

MeasureTime frame
Wound healing time. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination and visual inspection.;Wound size. Timepoint: Every 3 days to 21 days. Method of measurement: Visual inspection and ruler.;Pain. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMazaher Gholipourmalekabadi

Iran University of Medical Sciences

mazaher.gholipour@gmail.com+98 21 8670 4614

Outcome results

None listed

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