Enzymatic removal of dead tissues in patients (adults) with partial thickness and full thickness skin burns.

• Conditions: Eschar removal from partial thickness and full thickness burns; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2013-000057-44-SE
• Lead Sponsor: Mediwound Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-08
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Males and females between 18 years and 70 years of age
2. Thermal burns caused by fire/flame, scalds or contact
3. Partial Thickness (mid & deep dermal) and Full Thickness burn wounds = 4% and = 30% Total Body Surface Area (TBSA)
4. Total burn wounds = 30% TBSA
5. 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,
6. Signed written informed consent.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Beaux index > 80
2. 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)
3. Electrical or Chemical burns
4. Deep partial thickness and/or full thickness facial burn wounds >0.5% TBSA; study treatment of facial burns is not allowed
5. 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
6. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling = 80% of the trunk circumference),
7.
a. The following pre enrolment dressings: a. Flamacerium,
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)
8. Pre-enrolment escharotomy
9. Heavily contaminated burns or pre-existing infections as determined by the treating physician/investigator based on a combination of parameters such as temperature (=39°C) WBC (= 20.0 X 103 cells/µL) and and wound discharge.
10. Any signs or history that may indicate smoke inhalation (e.g. flame burn to the upper body, flames in enclosed space, smoke and fumes on the patient and in mouth and nostrils, deep flame burns >1 %TBSA to the face, cough, hoarseness, stridor or breathing difficulty including tachypnea possibly related to smoke inhalation, etc.),
11. Prisoners
12. Pregnant women (positive pregnancy test) or nursing mothers
13. Poorly controlled diabetes mellitus (HbA1c>9%)
14. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases)
15. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins)
16. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease)
17. Chronic systemic steroid intake
18. History of allergy and/or known sensitivity to pineapples or papain
19. Current suicide attempt
20. Participation in another investigational drug trial
21. Current alcohol or drug abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary endpoint is safety as measured by:<br>Systemic and local adverse events,<br>Changes in vital signs and laboratory tests,<br>Time to wound closure.<br>;Timepoint(s) of evaluation of this end point: Day 1 - Day 7 (Every day)<br>Day 7 - Wound closure (one a week)<br>1 month after wound closure;Main Objective: To evaluate the safety and efficacy (exploratory) of NexoBrid1 in hospitalized patients with Partial Thickness (mid and deep dermal) and/or Full Thickness thermal burns of 4-30% TBSA, but with total burn wounds of no more than 30% TBSA.<br>;Secondary Objective: To explore NexoBrid absorption as measured by Pharmacokinetic testing.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary endpoints specified, only exploratory endpoints.<br><br>Timely eschar removal (debridement)<br><br>% Treated wound excised (by tangential/minor/Versajet excision) or dermabraded in the first surgery. Surgical excision/dermabrasion performed in first surgery is defined as tangential/minor/Versajet excision or dermabrasion performed as the first surgical debridement performed after initial eschar removal (debridement) with NexoBrid<br><br>% Treated wound autografted of Partial Thickness (mid and deep dermal) burns. The sum of all post-debridement autografts performed will be taken<br><br>Pharmacokinetic evaluation;Timepoint(s) of evaluation of this end point: Day 1 - Day 7 (Every day)<br>Day 7 - Wound closure (one a week)<br>1 month after wound closure