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Clinical trials for TBSA

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    24 result(s) found for: TBSA. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2005-003662-41 Sponsor Protocol Number: MW-2004-11-02 Start Date*: 2005-11-24
    Sponsor Name:MediWound Ltd
    Full Title: Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
    Medical condition: Burn wounds defined as deep partial thickness or full thickness thermal burns.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SK (Completed) PT (Completed) CZ (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-000057-44 Sponsor Protocol Number: MW2008-09-03 Start Date*: 2013-09-05
    Sponsor Name:Mediwound Ltd
    Full Title: Feasibility Study: Enzymatic Debridement in Patients (Adults) with Partial Thickness and Full Thickness Burns - Protocol MW 2008-09-03
    Medical condition: Eschar removal from partial thickness and full thickness burns
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000940-26 Sponsor Protocol Number: CASM981C2314 Start Date*: 2004-09-24
    Sponsor Name:Novartis Pharma
    Full Title: A 22-week randomized, multicenter, parallel-group, double-blind study to compare a pimecrolimus 1 % (Elidel) twice daily (b.i.d.) maintenance dosing regimen to a once daily (o.d.) maintenance dosin...
    Medical condition: Atopic dermatitis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-005092-18 Sponsor Protocol Number: CS I-020502/01 Start Date*: 2007-01-08
    Sponsor Name:KUROS BIOSURGERY AG
    Full Title: A phase 2a, multi-centre, controlled study of the safety and efficacy of wound healing gel I-020502 in patients undergoing autologous meshed skin grafting.
    Medical condition: Deep partial-thickness and full-thickness burns require grafting procedures to achieve wound healing and closure. Autologous grafting eliminates the risk of transmissible diseases but may be compli...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10053615 Thermal burn LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003066-24 Sponsor Protocol Number: MW2012-01-01 Start Date*: 2014-12-17
    Sponsor Name:MediWound Ltd.
    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 (SO...
    Medical condition: The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compa...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004863 10043418 Thermal burns HLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) SK (Completed) DE (Completed) BE (Completed) AT (Prematurely Ended) BG (Prematurely Ended) NL (Prematurely Ended) FR (Completed) SE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005037-39 Sponsor Protocol Number: KEKLUKACS-CLIN-01 Start Date*: 2012-04-17
    Sponsor Name:Lukács és Társa Gyógyszerkereskedelmi Betéti Társaság
    Full Title: A Phase II Randomized, Controlled Parallel-Group Pilot Study to Assess the Safety and Efficacy of Kék Lukács Ointment Compared to Standard Silver Sulphadiazine (Dermazin®, SSD) Therapy in the Wound...
    Medical condition: Patients with burn injuries confined to the trunk and/or upper and lower extremities. Total burn area for all burns on a single patient should be no greater than 15% of TBSA. Patients’ total study ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001672-55 Sponsor Protocol Number: MW2010-03-02 Start Date*: 2014-09-22
    Sponsor Name:MediWound Ltd.
    Full Title: A multicenter, multinational, randomized, controlled, assessor blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid compared to Gel Vehicle and c...
    Medical condition: The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar in hospitalized subjects with thermal burns.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004863 10043418 Thermal burns HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) RO (Completed) LV (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-004541-34 Sponsor Protocol Number: 21092005 Start Date*: 2006-02-14
    Sponsor Name:South Manchester University Healthcare Trust
    Full Title: The Effect of Enteral Administration of Synbiotics Upon Infection Rates in Major Burns
    Medical condition: Major burn injuries: Thermal related trauma with burn injury involving significant proportions of the total body surface area, as defined by age: Adults (>=17 years old): >= 15% body surface area ...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-005124-42 Sponsor Protocol Number: KEKLUKACS-CLIN-02 Start Date*: 2014-03-17
    Sponsor Name:Lukács és Társa Gyógyszerkereskedelmi Betéti Társaság
    Full Title: A Phase II/III Adaptive, Seamless, Prospective, Randomized, Controlled, Parallel, Open Multicenter Study to Assess the Safety and Efficacy of Kék Lukács Ointment Compared to Standard Silver Sulfadi...
    Medical condition: Partial thickness (second-degree) burns. Total study target burn area: > 25 cm2 < 400 cm2 (or 2% of TBSA), and the burn therapy begun within 6-72 hours.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2007-004296-19 Sponsor Protocol Number: NBS07.116 Start Date*: 2008-02-07
    Sponsor Name:Association of Dutch Burn Centres
    Full Title: Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing
    Medical condition: Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006795 Burns extensive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-005115-17 Sponsor Protocol Number: CS I-020502/02 Start Date*: 2009-09-23
    Sponsor Name:Kuros Biosurgery AG
    Full Title: A phase 2b, multi-centre, randomized, intra-patient-controlled dose-finding study of I-020502 in patients undergoing autologous meshed skin grafting.
    Medical condition: acute wounds / deep partial and full thickness burns
    Disease: Version SOC Term Classification Code Term Level
    9.1 10043418 Thermal burns HLT
    9.1 10006802 Burns second degree LLT
    9.1 10006803 Burns third degree LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002460-41 Sponsor Protocol Number: TBRU-dS-BA-PIIb Start Date*: 2018-10-29
    Sponsor Name:CUTISS AG
    Full Title: A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for th...
    Medical condition: Adults and adolescents with partial deep dermal and full thickness burns
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002461-21 Sponsor Protocol Number: TBRU-dS-BC-PIIb Start Date*: 2018-10-29
    Sponsor Name:CUTISS AG
    Full Title: A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for th...
    Medical condition: Children with partial deep dermal and full thickness burns
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003481-28 Sponsor Protocol Number: RRK5108 Start Date*: 2017-12-21
    Sponsor Name:University Hospitals Birmingham NHS Foundation Trust
    Full Title: A pilot randomised controlled trial to examine the efficacy and optimal dose of Acetic Acid to treat colonised burns wounds.
    Medical condition: Colonised burn wounds
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022117 - Injury, poisoning and procedural complications 10053615 Thermal burn PT
    20.0 10021881 - Infections and infestations 10051548 Burn infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-005734-18 Sponsor Protocol Number: VOLU-011-CP4 Start Date*: 2012-07-23
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: Prospective randomised controlled open-label explorative multi-centre pilot trial of Volulyte®-supplemented versus Albumin-supplemented fluid resuscitation for major burns
    Medical condition: patients with major burns
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004826-12 Sponsor Protocol Number: MAP4B-safety Start Date*: 2021-07-27
    Sponsor Name:Association of Dutch Burn Centres
    Full Title: Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients
    Medical condition: Severe Burns
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002396-34 Sponsor Protocol Number: APHP180605 Start Date*: 2019-12-23
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (APHP)
    Full Title: Antibioprophylaxis for excision-graft surgery in burn patient: a multicenter randomized double-blind study
    Medical condition: excision-graft surgery in burn patient with a TBSA% between 5% and 40%
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004863 10006764 Burn of unspecified site, unspecified degree LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000362-38 Sponsor Protocol Number: BBW-11 Start Date*: 2012-06-18
    Sponsor Name:Birken AG
    Full Title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in...
    Medical condition: Superficial partial-thickness (grade 2a) burn wounds
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10006802 Burns second degree PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-000901-21 Sponsor Protocol Number: 2013.03 Start Date*: 2013-10-24
    Sponsor Name:Rode Kruis Ziekenhuis
    Full Title: A randomized clinical trial on the effectiveness, cost-effectiveness and quality of life of Flaminal® versus Flammazine® in the treatment of superficial and deep partial thickness burns
    Medical condition: Patients with partial thickness burns and/ or mixed depth of partial and full thickness burns
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004863 10015723 Extensive burns LLT
    14.1 100000004863 10006796 Burns eyes LLT
    14.1 100000004863 10006795 Burns extensive LLT
    16.0 100000004863 10006794 Burns classified according to extent of body surface involved LLT
    14.1 100000004863 10043441 Third degree burns LLT
    14.1 100000004863 10006801 Burns of multiple specified sites, unspecified degree LLT
    16.0 100000004863 10012087 Deep necrosis of underlying tissues due to burns (dtd) of multiple specified sites w/o mention lobp LLT
    14.1 100000004863 10028175 Multiple burns LLT
    14.1 100000004863 10039798 Second degree burns LLT
    16.0 100000004863 10031700 Other burns of eyelids and periocular area LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002066-32 Sponsor Protocol Number: BEB-13 Start Date*: 2017-11-10
    Sponsor Name:Amryt Research Limited
    Full Title: Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa
    Medical condition: Inherited Epidermolysis Bullosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10014989 Epidermolysis bullosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) AT (Completed) DE (Completed) ES (Ongoing) GR (Completed) HU (Completed) CZ (Completed) BE (Completed) DK (Completed) IT (Completed) HR (Completed) FR (Completed) RO (Ongoing)
    Trial results: View results
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