Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings
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|ClinicalTrials.gov Identifier: NCT03190655|
Recruitment Status : Terminated (Stopped by the Sponsor due to their change in product development priorities.)
First Posted : June 19, 2017
Last Update Posted : March 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Partial-thickness Burn||Device: Aluminaid Device: Hydrogel||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Masking:||Double (Care Provider, 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.|
|Official Title:||Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings in the Treatment of Partial Thickness Burns|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||March 5, 2018|
|Actual Study Completion Date :||March 5, 2018|
Treatment group: Aluminaid wound dressing
Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium
Active Comparator: Hydrogel
Hydrogel wound dressing (Trademark: Burnshield)
Hydrogel based wound dressing
- Wound healing [ Time Frame: Up to 21 days ]Wound healing as determine by the time of complete re-epithelization of the study area, in days.
- Erythema [ Time Frame: at the time of admission up to 30 minutes ]The presence of erythema
- Bullae [ Time Frame: at the time of admission up to 30 minutes ]The presence of bullae
- Pain score [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190655
|Clinic of Clinical Research Supporting Unit|
|Jakarta Pusat, Jakarta, Indonesia, 10430|
|Principal Investigator:||Wawaimuli Arozal, MD, PhD||Indonesia University|