Condition 1: Acute second-degree burn wound on the upper limbs. Condition 2: Acute second degree burn wound in trunk. Condition 3: Acute second-degree burn wound on the lower limbs. Condition 4: Acute second degree burn wound involving 25-40% of body surface. Condition 5: Acute second degree burn wound involving 25-40% of body surface. Burn of second degree of shoulder and upper limb, except wrist and hand Burn of second degree of trunk Burn of second degree of lower limb, except ankle and fo
Conditions
Interventions
Intervention group: A deep second-degree burn wound of 60 cm2 in limbs or trunk (except joints, arms, legs, and areas where tendons, blood vessels, or bone tissue are exposed) will be selected. This a
Sponsors
ATI tech pharmed
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age between 18-70 years Acute second-degree heat burns involving 25-40% of the body surface Existence of at least one deep second-degree burn wound with 60 cm2 in area in the trunk or limbs (except the joints and arms & feet) in which tendons, blood vessels, or bone tissue is not exposed Declaration of written consent to participate in the study and willingness to attend regular treatment and follow-up courses
Exclusion criteria
Exclusion criteria: Chronic uncontrolled underlying disease (vascular disease, diabetes, malnutrition, hypertension, cardiovascular disease) Known underlying psychiatric illness Pregnancy or breastfeeding History of cancer or chemotherapy Infection with viral diseases (HCV, HBV, HIV) History of organ transplantation or blood transfusion History of taking immunosuppressive or cytotoxic drugs during the last 6 months Respiratory injury Requires special care Multiple trauma (fracture, or thoracic, abdominal, or CNS trauma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No observed short-term or long term, systemic or local, severe or mild, and related or unrelated to cell therapy adverse effects. Timepoint: before the intervention, 3, 7, 10, 14, 21, 28 days, 3, and 6 months after the intervention. Method of measurement: CTCAEV5 methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of wound epithelialization. Timepoint: 3, 7, 10, 14, 21, 28 days after intervention. Method of measurement: Solar calender.;Graft take rate. Timepoint: 3, 7, 10, 14, 21, 28 days after intervention. Method of measurement: Physician evaluation.;Scar assessment. Timepoint: 3 and 6 months after the intervention. Method of measurement: Based on Patient and Observer Scar Assessment Scale (POSAS) score.;Scar assessment. Timepoint: 3 and 6 months after the intervention. Method of measurement: Based on (VSS) Vancouver scar scale score.;Wound closure and scar shape. Timepoint: 3, 7, 10, 14, 21, 28 days and 3 and 6 months after the intervention. Method of measurement: Based on 2D photography by Canon powershot S5Is.;Skin structure and quality improvement. Timepoint: 6 months after the intervention. Method of measurement: Pathological criteria include H&E staining (hematoxylin and eosin), MT (Masson’s Trichrome), and immunohistochemistry (TGFß-1,3, collagen 1,3 vimentin, a-SMA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShayan Farzanbakhsh
Royan Institute
Outcome results
None listed