Children Innovative Debridement Study (CIDS) MW2012-01-01
Research type
Research Study
Full title
A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment
IRAS ID
169217
Contact name
Roy Eshet
Contact email
Sponsor organisation
MediWound Ltd.
Eudract number
2014-003066-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 2 months, 6 days
Research summary
When a person burns their skin there is damaged tissue. This damaged tissue needs to be removed before healing can begin. If it is not removed quickly there is a higher risk of infection as well the risk of more scarring if the wound takes longer to heal.
MediWound Ltd has developed Nexobrid®, a gel containing proteins called enzymes that come from the stem of the pineapple plant. These enzymes can remove or break down unhealthy tissue without causing harm to healthy tissue. Treatment with Nexobrid® can be started soon after a burn has occurred. Removing unhealthy tissue at an early stage may avoid the need for surgery. Nexobrid® can also be used in emergency situations where deep burns sometimes cause a tightening of the tissues where normally an operation is needed to release the tissues.
Nexobrid® can be used in burns that are difficult to judge in terms of their depth. Deep burns (these are burns that damage the whole thickness of the skin or almost all of it) need surgery but superficial ones don’t so often there is a delay in deciding the right treatment until it is clear if surgery is required or not. This may take a few days. As Nexobrid® only removes unhealthy tissue it can be used to remove damaged tissue much sooner.
Nexobrid® was approved for use in adults in some European countries in 2012 but it is not yet approved for use in children. This study has been designed to collect information on its use in children.
The main aims of this study are to assess the safety and benefits of Nexobrid® in children of all ages who have burns which are deep and are of a size between 1 and 30% of the total body surface area. Nexobrid® will be compared to the standard treatment normally used for children with such burns.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/0241
Date of REC Opinion
29 Dec 2015
REC opinion
Further Information Favourable Opinion