Partial thickness (second-degree) burns. Total study target burn area: > 25 cm2 < 400 cm2 (or 2% of TBSA), and the burn therapy begun within 6-72 hours.
Conditions
Interventions
Product Name: Kék Lukács Ointment
Pharmaceutical Form: Ointment
INN or Proposed INN: AZITHROMYCIN
CAS Number: 83905-01-5
Other descriptive name: AZITHROMYCIN
Concentration unit: mg/g milligram(s)/gram
Sponsors
Lukács és Társa Gyógyszerkereskedelmi Betéti Társaság
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent by the patient after information about the study. Age above 18 years. Female patients with childbearing potential with a negative result from pregnancy test at inclusion, who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial. Thermal origin burns. Total burn area for all burns on a single patient should not be greater than 15 % of TBSA. Patients with burn injuries confined to the trunk and/or upper and lower extremities. Patients’ total study target burn area (second-degree) should be greater than 25 cm2 but no greater than 400 cm2 (or 2% of TBSA), and the burn therapy started within 6-72 hours. According to the investigator’s opinion local antimicrobial treatment is required due to infectious risk, the wound is suitable for SSD treatment. Able to communicate well with the investigator and comply with the study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: Patients with significant co-morbid conditions like chronic respiratory illness, ischemic or other cardiac disease and/or diabetes, immunodeficiency. Patients with inhalation burn injury. Burns >15 % TBSA. Patients with known or suspected allergy to any of the components of Kék Lukács ointment or SSD cream. Head, face genitalia, palms of hands, soles of feet are excluded as test sites. Circumferential burns. Electrical and/or chemical burns. Clinically significant systemic infections requiring systematic antibiotic treatment. Patients with vascular or skin disorders that directly affect the designated wound site. Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion compromise study participation. Lactation, pregnancy or women of childbearing potential not practicing an adequate method of contraception. Preliminary systematic/local antibiotic or antimicrobial (Dermazin cream) treatment at the inclusion. Participation in a clinical trial within 30 days before start of the trial. History of drug and/or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective To compare the clinical efficacy of Kék Lukács ointment treatment with standard Dermazin® (SSD) therapy in wound healing; with 3D photo documentary every second day from the first day of treatment till the 22th day of treatment or till healing of the wound; by evaluating the days needed to the wound healing. ;Secondary Objective: 1. Investigator‘s assessment of signs of wound infection and inflammation: a) oozing, b) erythema, c) warmth, d) oedema, e) pain, f) odour. 2. Clinical assessment of the wound bed and wound margin on each medical visit in treatment and follow up periods of the study 3. To monitor the wound surface and wound secretion on the treatment days. 4. To assess the change in degree of epithelization of wound comparing to day 1 on each clinical visit from the second day of the study till reaching 91% epithelization. 5. To assess the tolerability of local therapy of target wound based on sensitivity and local irritability on every day during treatment period. 6. To evaluate the satisfaction of cosmetic result after Kék Lukács Ointment treatment through the evaluation of general wound appearance, crusting and scabbing comparing to Dermazin® (SSD) tretment. 7. To assess the ease of application of Kék Lukács Ointment. 8. To collect pharmacoeconomic information.;Primary end point(s): The primary endpoint of this study will be the number of days until wound healing. Wound healing will be attained on the first day when the wound area (as measured by planimetry, taking the mean of the values evaluated by two independent assessors) will be below 10% of the baseline wound area. Wound area will be measured in each two days starting from baseline, and no interpolation for wound area will be performed. A wound is considered to be healed on the first day when the unhealed wound extent decreases under 10% of the original wound extent. For patients by whom treatment was continued by surgery the day of or | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of signs of wound infection and inflammation: a) oozing, b) erythema, c) warmth, d) oedema, e) pain, f) odour. 2. Clinical assessment of the wound bed and wound margin. 3. Monitoring wound surface and wound secretion on the treatment days. 4. Assessment of percent change of wound surface on each clinical visit. 5. Evaluation of satisfaction of cosmetic results after Kék Lukács Ointment treatment. 6. Detection of incidence of suitability for skin transplant. 7. Assessment of the ease of application of Kék Lukács Ointment. 8. Collection of pharmacoeconomic information. ;Timepoint(s) of evaluation of this end point: Day 1 to Day 28 | — |
Countries
Hungary
Contacts
Public ContactKÉKLUKÁCS Help Desk
AdWare Research Ltd.
Outcome results
None listed