Second Degree Burn. Burns involving 10-19% of body surface
Conditions
Interventions
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
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
Silver Sulfadiazine 1% impregnated gauze pieces after washing them with normal saline and will be re-applied daily
Sponsors
Parsroos Biotechnology Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Parviz Hosseini
Parsroos Biotechnology Company
Outcome results
None listed