Clinical trial NCT03190655: Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings
Official title: Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings in the Treatment of Partial Thickness Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Partial-thickness Burn
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who attend the clinical sites, presenting with untreated partial thickness burns less than 4 hours, and meet the inclusion and exclusion criteria
Primary purpose: TREATMENT

Brief summary: Burn injury is the result of an energy transfer that destroys the skin and adjacent tissues. Partial thickness burn wounds are painful and difficult to manage. The aim of burn treatment in partial thickness burns is to promote rapid wound healing, decrease pain, protect wound from infections, minimize scar formation and functional impairment In recent years, there are progressive development of new dressing material with a variety of option for depth adapted wound management. Many wound dressings are available for superficial and partial thickness burns. Hydrogel based wound dressing provides good biocompatibility with the skin and mucosa and promotes hydration of the wound bed.

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.

Detailed description: This is a prospective, randomized, open label, active controlled trial that aim to evaluate the efficacy and safety of Aluminaid versus Hydrogel wound dressings in the treatment of partial thickness burns.

The study is a multi center trial in children and adults of 12 - 65 years old with partial thickness burns.

Eligibility criteria: Inclusion Criteria:

* Adults and children of 12 - 65 years old
* 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:

* Total body surface area (TBSA) of more than 20%
* 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)

Primary outcomes:
measure: Wound healing
timeFrame: Up to 21 days
Secondary outcomes:
measure: Erythema
timeFrame: at the time of admission up to 30 minutes
measure: Bullae
timeFrame: at the time of admission up to 30 minutes
measure: Pain score
timeFrame: At the time of admission up to 30 minutes and 1st week of follow up
measure: Adverse events
timeFrame: At the time of admission up to 21 days of follow up
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Clinic of Clinical Research Supporting Unit
state: Jakarta
Study officials:
affiliation: Indonesia University
name: Wawaimuli Arozal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
citation: 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.
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