Partial-thickness Burn
Conditions
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.
Interventions
DEVICEAluminaid
Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium
DEVICEHydrogel
Hydrogel based wound dressing
Sponsors
Melva Louisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The person that assess the degree of epithelization will be presented with photos of the burn conditions and will not be given information of the patient's treatment.
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
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | Up to 21 days | Wound healing as determine by the time of complete re-epithelization of the study area, in days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema | at the time of admission up to 30 minutes | The presence of erythema |
| Bullae | at the time of admission up to 30 minutes | The presence of bullae |
| Pain score | At the time of admission up to 30 minutes and 1st week of follow up | Pain score is determined by VAS score (1 - 10: 1 is no pain 10 is severe pain). |
| Adverse events | At the time of admission up to 21 days of follow up | The adverse events in patients treated with Aluminaid versus Hydrogel as determined by the proportion of patients who experience adverse events |
Countries
Indonesia
Outcome results
None listed