Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings
NCT ID: NCT03190655
Last Updated: 2018-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2017-03-01
2018-03-05
Brief Summary
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Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium that was designed to reduce acute pain in the treatment of superficial and partical thickness burn injuries.
Up to date, no evidence regarding integrated with aluminium sheet in hydrogel based wound dressings for the use in partial thickness burns. Therefore this trials is aimed to evaluate the efficacy and safety of Aluminaid versus Hydrogel for the treatment of partial thickness burns.
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Detailed Description
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The study is a multi center trial in children and adults of 12 - 65 years old with partial thickness burns.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aluminaid
Treatment group: Aluminaid wound dressing
Aluminaid
Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium
Hydrogel
Hydrogel wound dressing (Trademark: Burnshield)
Hydrogel
Hydrogel based wound dressing
Interventions
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Aluminaid
Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium
Hydrogel
Hydrogel based wound dressing
Eligibility Criteria
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Inclusion Criteria
* Partial thickness thermal burns of minimally 1% total body surface area (TBSA)
* Admission of less than 4 hours of burn injury
* Patients/legal guardian still have the ability to undergo examinations and give written informed consent.
Exclusion Criteria
* Burns caused by chemicals, electricity or radiation
* Superficial and partial thickness burns located on the faces, palms, soles, genitalia, perineum and joint areas
* Superficial and partial thickness burns with compartment syndrome
* Superficial and partial thickness burns with a history of life-threatening trauma
* Had concomitant disease such as diabetes mellitus
* Signs of infected burns
* Patients with known allergies to product containing aluminium, hydrogel or a history of contact dermatitis
* Other conditions which according to the investigator's judgment are not appropriate to be included in the study.
* Treated with other agents before attend to clinic (oil, tooth paste, betadine, rivanol etc)
12 Years
65 Years
ALL
No
Sponsors
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Melva Louisa
OTHER
Responsible Party
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Melva Louisa
Trial Director
Principal Investigators
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Wawaimuli Arozal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Clinic of Clinical Research Supporting Unit
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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References
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Grippaudo FR, Carini L, Baldini R. Procutase versus 1% silver sulphadiazine in the treatment of minor burns. Burns. 2010 Sep;36(6):871-5. doi: 10.1016/j.burns.2009.10.021. Epub 2010 Jan 15.
Cancio LC, Lundy JB, Sheridan RL. Evolving changes in the management of burns and environmental injuries. Surg Clin North Am. 2012 Aug;92(4):959-86, ix. doi: 10.1016/j.suc.2012.06.002.
Hettiaratchy S, Dziewulski P. ABC of burns: pathophysiology and types of burns. BMJ. 2004 Jun 12;328(7453):1427-9. doi: 10.1136/bmj.328.7453.1427. No abstract available.
Lars PK, Giretzlehner M, Trop M, Parvizi D, Spendel S, Schintler M, Justich I, Wiedner M, Laback C, Lumenta DB. The properties of the "ideal" donor site dressing: results of a worldwide online survey. Ann Burns Fire Disasters. 2013 Sep 30;26(3):136-41.
Rowan MP, Cancio LC, Elster EA, Burmeister DM, Rose LF, Natesan S, Chan RK, Christy RJ, Chung KK. Burn wound healing and treatment: review and advancements. Crit Care. 2015 Jun 12;19:243. doi: 10.1186/s13054-015-0961-2.
Selig HF, Lumenta DB, Giretzlehner M, Jeschke MG, Upton D, Kamolz LP. The properties of an "ideal" burn wound dressing--what do we need in daily clinical practice? Results of a worldwide online survey among burn care specialists. Burns. 2012 Nov;38(7):960-6. doi: 10.1016/j.burns.2012.04.007. Epub 2012 May 8.
Serrano C, Boloix-Tortosa R, Gomez-Cia T, Acha B. Features identification for automatic burn classification. Burns. 2015 Dec;41(8):1883-1890. doi: 10.1016/j.burns.2015.05.011. Epub 2015 Jul 15.
Wasiak J, Cleland H, Campbell F, Spinks A. Dressings for superficial and partial thickness burns. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD002106. doi: 10.1002/14651858.CD002106.pub4.
Other Identifiers
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Aluminaid
Identifier Type: -
Identifier Source: org_study_id
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