An interventional study of Aluminaid and Hydrogel in Partial-thickness Burn, sponsored by Melva Louisa. Terminated at 1 site in Indonesia. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Melva Louisa · Not applicable, Interventional, and Treatment
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.
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.
Melva Louisa is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment group: Aluminaid wound dressing
Device: Aluminaid
Hydrogel wound dressing (Trademark: Burnshield)
Device: Hydrogel
Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium
Hydrogel based wound dressing
Wound healing
Wound healing as determine by the time of complete re-epithelization of the study area, in days.
Time frame: Up to 21 days
Erythema
The presence of erythema
Time frame: at the time of admission up to 30 minutes
Bullae
The presence of bullae
Time frame: 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).
Time frame: 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
Time frame: At the time of admission up to 21 days of follow up
Plan to share: No
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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