Status:
COMPLETED
Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns
Lead Sponsor:
MediWound Ltd
Conditions:
Burn
Eligibility:
All Genders
4-55 years
Phase:
PHASE2
Brief Summary
Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is the source of l...
Detailed Description
on-going recruitment, children and adults
Eligibility Criteria
Inclusion
- Males and females between 2 years and 55 years of age,
- Thermal burns caused by fire/flame, scalds or contact,
- Burn composition must be as follows:
- Partial Thickness (mid \& deep dermal) burn wounds ≥ 4% and ≤ 30% Total Body Surface Area (TBSA),
- Full thickness burns ≤ 5%,
- All the partial and full thickness burn wounds must receive study treatment except facial, genital or perineal burns (Exclusion Criteria #5 and #6 below),
- Total burn wounds ≤ 30% TBSA,
- Hospital admission within 24 hours of the burn injury. Patients transferred from another hospital/clinic may be enrolled if the primary admission was within 24 hours of the burn injury and admission to the burn unit participating in the study was within 48 hours of the burn injury,
- Signed written informed consent.
Exclusion
- More than 5% TBSA full thickness burns,
- Patient having only full thickness burns,
- Other severe cutaneous trauma at the same sites as the burns (i.e. considerable blunt, avulsion or deep abrasion), or previous burn(s) at the same treatment site(s),
- One or more burn wounds that do not meet study criteria,
- Deep partial thickness and/or full thickness facial burn wounds \>0.5% TBSA; study treatment of facial burns is not allowed,
- Study treatment of perineal and/or genital burns is not allowed; A patient with these wounds may be enrolled but the wounds may not be designated as target wounds,
- Patient with circumferential anterior/posterior trunk fire/flame burns, \>15% TBSA Circumferential is defined as encircling ≥ 80% of the trunk circumference),
- A. The following pre enrolment dressings: a. Flammacerium, b. Silver Nitrate AgNO3), B. Pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment);
- Pre-enrolment escharotomy,
- Heavily contaminated burns or pre-existing infections (Adults: WBC ≥ 20.0 X 103 cells/µL; Children aged 4-18: WBC ≥ 25.0 X 103 cells/µL)),11.Signs that may indicate smoke inhalation (e.g. clinical signs, etiology of injury, venue of injury, etc.),
- Children with Hb \< 10 gm/dl at Screening/Pre treatment
- Prisoners,
- Pregnant women (positive pregnancy test) or nursing mothers,
- Poorly controlled diabetes mellitus (HbA1c\>9%),
- Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
- Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins),
- Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease),
- Chronic systemic steroid intake,
- History of allergy and/or known sensitivity to pineapples or papain,
- Current suicide attempt,
- Participation in another investigational drug trial,
- Current alcohol or drug abuse,
Key Trial Info
Start Date :
December 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00898521
Start Date
December 20 2009
End Date
December 2 2015
Last Update
September 9 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Lok Nayak hospital
New Delhi, India
2
Soroka University Medical Center
Beersheba, Israel