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IRCT138808062587N2 IRCT 2010-01-27 Parsroos Biotechnology Company Assessing Carbon Selenium Complex healing effect on partial thickness burns Safety and Efficacy of Carbon Selenium Complex in Second Degree Burns: A Randomized Clinical Trial 2009-12-05 anticipated 200 Complete https://irct.ir/trial/2367 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Second Degree Burn. Intervention 1: Carbon Selenium Complex 1.5%, once daily, will be applied as a thin smear of approximately 2 mm in quantities depending on the size of the burn to the surface of the greatest wounds in size after the burn is washed with normal saline. Intervention 2: Silver Sulfadiazine 1% impregnated gauze pieces after washing them with normal saline and will be re‐applied daily.
public Dr. Parviz Hosseini
No 568, 13th Alley, Hormozan St., Shahrak-e-Gharb, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 8837 0763 dr.p.hosseini@gmail.com Parsroos Biotechnology Company scientific Dr. Farhad Gharibdoust
Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8837 0763 gharibdoost@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: Each involved patient should be stable in condition and not need resuscitation; Thermal flame or scald injury; Admitted within 24 hours after the injury; Clean noninfected wound as diagnosed by the attending physician; The wounds with comparable size and treatment prior to the screening visit; The size of the burn wounds to be assessed is required to be at least 15 cm2 but no more than 300 cm2; In case of more than one burned wound in the same individual as described above, the wound with the greatest surface area will be selected for study; The burn area less than 20% and more than 1% total body surface area (TBSA); Age from 18 to 65 years; Weight up to 100 kg; Patients will be eligible for the study if written informed consent is obtained from each participant. Exclusion Criteria: Burn injury occurrence >24 h prior to commencement of treatment; Full-thickness burns; Wounds noted to be contaminated or infected; Burns in special areas such as the face, fingers, axillary, perineal or inguinal region, deep body folds, or a distinctive adipose tissue region and finally, massive burns in joints; Drug allergy histories or known hypersensitivity to silver sulfadiazine or any other ingredient of the study medications; Contraindications for the use of topical preparations containing silver sulfadiazine; Pregnancy; Alcohol or drug abuse; Significant organ dysfunctions such as renal failure, CHF, and liver dysfunction; Cancer; Vascular diseases; Immunosuppressive disorders; Inhalation injury; Simultaneous burn and trauma; Abnormal liver enzymes and total bilirubin > 1.5 times of normal upper limit 18 years 65 years Both T31.1 Burns involving 10-19% of body surface Treatment - Drugs Treatment - Drugs Carbon Selenium Complex 1.5%, once daily, will be applied as a thin smear of approximately 2 mm in quantities depending on the size of the burn to the surface of the greatest wounds in size after the burn is washed with normal saline Silver Sulfadiazine 1% impregnated gauze pieces after washing them with normal saline and will be re‐applied daily The number of days until wound closure (≥ 90% re-epithelialization). Timepoint: Study wounds will be evaluated, beginning at day 2 after treatment and at least every other day thereafter. Method of measurement: By wound re-epithelialization assessments, the percentage of wounds closure will be assessed by the same investigator through visual estimation, to the nearest 5%, up to 90% and by single percentage points above 90%. The appearance of new tissue at the wound edge can be measured in centimeters or by the percentage of wound coverage. Then, the number of days taken for complete re-epithelialization to occur will be recorded. The analgesic effect. Timepoint: Every other day from first day of treatment. Method of measurement: By visual analogous scale (VAS), itching (5‐point scale), and sensation during change of dressing (4‐point scale). The quality of wound healing. Timepoint: Every other days from third day of treatment. Method of measurement: According to elasticity, smoothness, and appearance of the wound. Adverse effects. Timepoint: During treatment period. Method of measurement: According to any toxicity evidence or dermal abnormal sign indicating rashes, post positive swelling or inflammation, redness, irritation, pain, itching, necrosis, scar formation, and systemic adverse events. The number of partial thickness healed wounds in the 21st day of intervention. Timepoint: The healing rate will be assessed every other day. Method of measurement: It will be determined by a surgeon. Wounds surface areas. Timepoint: Every other day. Method of measurement: It will be defined by wounds planimetry which will be performed by a surgeon. The number of dressing changes. Timepoint: Every day. Method of measurement: By counting the number of dressing changes. Wounds Infection. Timepoint: 1st, 2nd, 3rd, 10th, and 17th days. Method of measurement: According to positive or negative bacterial cultures. The burn complications (infection, scar formation, hypopigmentation). Timepoint: Every other day from third day of treatment. Method of measurement: According to bacteriological assessments and appearance of the wounds. The cosmetic results. Timepoint: Every other day from third day of treatment. Method of measurement: According to scar formation, hypopigmentation and the investigator idea. Number of days until the first appearance of granulation tissue. Timepoint: Every other day from third day of treatment. Method of measurement: It will be determined during each visit by a surgeon. The failure to heal. Timepoint: Every other day from third day of treatment. Method of measurement: According to very slow healing rate (5‐6 weeks) or the number of study wounds that require autografting. Parsroos Biotechnology Company Approved 2009-10-27 Avicenna Research Institute Ethics Committee Avicenna Research Institute, Shahid Beheshti University, Evin, Tehran, Iran Tehran Iran (Islamic Republic of)