Safety and effectiveness evaluations of amniotic membrane wound dressing

Not Applicable

Recruiting

• Conditions: Patients with second degree skin burns.; Burn of second degree of trunk; T21.2

• Registration Number: IRCT20230429058021N1
• Lead Sponsor: Sina Mehr Fajr Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.