SN514-066b Enzyme in Deep Partial Thickness Burns

Launched by SERDA BV · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial, called SN514-066b, is investigating a special gel containing an enzyme, SN514, to see how well it works for treating deep partial thickness burns. The study will involve patients who have specific types of thermal burns, such as those from fire or hot liquids. Participants will be treated with different strengths of the gel over a week, and researchers will check how well the gel helps in cleaning the burn wounds and whether any side effects occur. Everyone in the trial will receive the treatment, as all burn wounds require cleaning to heal properly.

To be eligible for this trial, participants should be between 18 and 75 years old and have burns that are not on the face, hands, or other sensitive areas. The burned area must be between 25 and 500 square centimeters. However, certain health conditions, like severe heart or lung problems, uncontrolled diabetes, or recent serious injuries, may prevent someone from joining. Participants can expect to have daily check-ins and treatments for up to seven days, with careful monitoring to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • 1. Thermal burns caused by fire/flame, scalds or contact
• • 2. Total burns area available for treatment is 25 to 500 cm2 (a larger area may be burned, but the treatment area must be limited to the stated size, and the treatment area must be exclusive of face, hands, genitalia and sites deemed to be at high risk for developing compartment syndrome)
• • 3. Target burns for treatment is deep partial thickness (DPT) in depth
• Main Exclusion Criteria:
• • 1. Subject has another life threatening traumatic injury
• 2. Patient's proposed study wound site has any of the following conditions:
• • Electrical or chemical etiology
• • Pre-enrollment escharotomy
• • Area is devoid of circulation
• • Located on the face, perineum or genitalia
• • Clinical evidence of wound infection
• • 3. Poorly controlled diabetes mellitus (HbA1c \>12%)
• • 4. BMI greater than 40 kg/m2
• • 5. Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable ischemic heart disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma, or uncontrolled asthma)
• • 6. Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins)
• • 7. Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury)