Safety and effectiveness evaluations of amniotic membrane wound dressing

Clinical trial of the decellularized amniotic membrane for dressing of skin wounds

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230429058021N1

Enrollment

Registered

2023-05-22

Start date

2023-05-22

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Patients with second degree skin burns. Burn of second degree of trunk

Interventions

Intervention 1: Intervention group: After selecting the patients and obtaining written consent from the patient or his/her legal guardian, the wound after washing with normal saline is covered with th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with skin wounds (second degree burn trauma) after entering the hospital.

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. Oposamniohyl 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

Measure	Time 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.;Wound granulation according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Observation by a wound specialist.;Redness, discharge, apparent infection, unpleasant odor and other inflammatory reactions according to the CRF form. 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.	—

Measure

Time 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.;Wound granulation according to the CRF form. Timepoint: 0, 3, 6, 9, 12, 15, 18 and 21 days after primary transplantation. Method of measurement: Observation by a wound specialist.;Redness, discharge, apparent infection, unpleasant odor and other inflammatory reactions according to the CRF form. 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.

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Secondary

Measure	Time 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.;Redness and inflammation. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination and visual inspection.;Pain. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination.	—

Measure

Time 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.;Redness and inflammation. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination and visual inspection.;Pain. Timepoint: Every 3 days to 21 days. Method of measurement: Patient examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Mellati

Mazandaran University of Medical Sciences

amirmellati@gmail.com+98 11 3325 1034

Outcome results

None listed

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