Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings

Melva Louisa

Status

Terminated

Conditions

Partial-thickness Burn

Treatments

Device: Hydrogel

Device: Aluminaid

Study type

Interventional

Funder types

Other

Identifiers

NCT03190655

Aluminaid

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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)