Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings in the Treatment of Partial Thickness Burns

Conditions
-----------------
Partial-thickness Burn

Intervention / Treatment
-----------------
* Device: Aluminaid
* Device: Hydrogel


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aluminaid<br>Treatment group: Aluminaid wound dressing | Device: Aluminaid<br>* Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium<br>|
| Active Comparator: Hydrogel<br>Hydrogel wound dressing (Trademark: Burnshield) | Device: Hydrogel<br>* Hydrogel based wound dressing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Wound healing as determine by the time of complete re-epithelization of the study area, in days. | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema | The presence of erythema | at the time of admission up to 30 minutes | 
| Bullae | The presence of bullae | at the time of admission up to 30 minutes | 
| Pain score | Pain score is determined by VAS score (1 - 10: 1 is no pain 10 is severe pain). | At the time of admission up to 30 minutes and 1st week of follow up | 
| Adverse events | The adverse events in patients treated with Aluminaid versus Hydrogel as determined by the proportion of patients who experience adverse events | At the time of admission up to 21 days of follow up |