Study to Evaluate the Performance and Safety of the Medical Device Argogen
Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III
About this trial
This is an interventional treatment trial for Burn Wound focused on measuring Burn Wound, Minor Burn Wounds, Superficial Burn Wounds, Deep Partial thickness Burn Wounds, Pressure ulcers, pressure sores, bed sores, decubitus ulcers
Eligibility Criteria
Inclusion Criteria: In- or outpatients of both sexes, of all ethnic backgrounds, aged between 18 and 75 years(inclusive). Patients presenting superficial / first degree and superficial / deep partial-thickness / second degree burn wound in less than 10% of total body surface area, for which the burning event occurred within 48 hours and that can be treated within 24 hours after enrolment in the study (at baseline) or patients presenting chronic pressure ulcers stage 2 or 3 (according to the NPUAP Classification) that did not heal within 3 weeks despite proper wound care, with areas (or scattered areas) of necrosis (nonviable soft tissue/slough) more than 40%, and with a target wound which is between 4 cm squared to 20 cm squared in area at the baseline assessment. Patients, who are, in the opinion of the Investigator, able to understand this study, cooperate with the study procedures and are willing to return to the centre (if outpatients) for all the required visits. Patients who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki and the Romanian laws. Exclusion Criteria: Severe heart (myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease. Medical history or not-treated diabetes mellitus or diabetic foot syndrome. Peripheral artery disease with ankle brachial index (ABI < 0.9). Thrombocytopenic patients (platelet <150.000 g/l; collected in last 3 months medical history).* Haemoglobin < 95 g/l (collected in last 3 months medical history).* Concomitant infection of another site or osteomyelitis or erysipelas or phlegmon. Complicated deep tissue infection requiring systemic antimicrobial therapy. Active viral hepatitis (A/B/C) or active HIV infection or active syphilis. Presence of neoplastic growth in the ulcer. History or clinical signs of impairment of the cochlea or vestibularis system. Neuromuscular diseases (i.e., myasthenia gravis, Parkinson's disease) Aminoglycoside treatment or other antibiotic treatments for chronic venous ulcers administered less than four weeks before inclusion. Concomitant administration of proteolytic enzymes or products containing proteolytic enzymes (i.e., bromelain, chymotrypsin, ficin, papain, serrapeptase, trypsin) during the whole study. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception** during the study. **Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.). Known allergy to the tested medical device and its components (in particular, allergy to silver). Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days. If such lab tests are not available at screening a blood sample can be collected for analyses. However, the patient can be enrolled and start immediately treatment. After Visit 1, the Investigator will examine the laboratory results, as soon as available, to determine patient continuation.
Sites / Locations
- MC Medica SRL
- SC Salvosan Ciobanca SRL
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Subjects affected by pressure ulcers
Subjects affected by burns
Percentage of subjects whose wounds condition is improved during the four-week treatment with the medical device evaluated by Investigator, according to the pressure ulcers evaluation of PUSH ver. 3.0 score (according to evaluation of the following parameters: length times width, exudate amount and tissue type), performed by the Investigator at 4 weeks after the initiation of treatment, compared to day 0 (baseline).
Percentage of subjects whose wounds condition is improved during the four-week treatment with the medical device evaluated by Investigator, according to the evaluation of burn wound VSS score (according to evaluation of the following parameters: vascularity, height/thickness, pliability and pigmentation), performed by the Investigator at 4 weeks after the initiation of treatment, compared to day 0 (baseline).