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Stopped by the Sponsor due to their change in product development priorities.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aluminaid | Experimental | Treatment group: Aluminaid wound dressing |
|
| Hydrogel | Active Comparator | Hydrogel wound dressing (Trademark: Burnshield) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aluminaid | Device | Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wawaimuli Arozal, MD, PhD | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Clinical Research Supporting Unit | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20079572 | Background | Grippaudo FR, Carini L, Baldini R. Procutase versus 1% silver sulphadiazine in the treatment of minor burns. Burns. 2010 Sep;36(6):871-5. doi: 10.1016/j.burns.2009.10.021. Epub 2010 Jan 15. | |
| 22850157 | Background | Cancio LC, Lundy JB, Sheridan RL. Evolving changes in the management of burns and environmental injuries. Surg Clin North Am. 2012 Aug;92(4):959-86, ix. doi: 10.1016/j.suc.2012.06.002. |
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| ID | Term |
|---|---|
| D047070 | Bandages, Hydrocolloid |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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Patients who attend the clinical sites, presenting with untreated partial thickness burns less than 4 hours, and meet the inclusion and exclusion criteria
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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.
| Hydrogel | Device | Hydrogel based wound dressing |
|
| 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 |
| 15191982 | Background | Hettiaratchy S, Dziewulski P. ABC of burns: pathophysiology and types of burns. BMJ. 2004 Jun 12;328(7453):1427-9. doi: 10.1136/bmj.328.7453.1427. No abstract available. |
| 24563639 | Background | Lars PK, Giretzlehner M, Trop M, Parvizi D, Spendel S, Schintler M, Justich I, Wiedner M, Laback C, Lumenta DB. The properties of the "ideal" donor site dressing: results of a worldwide online survey. Ann Burns Fire Disasters. 2013 Sep 30;26(3):136-41. |
| 26067660 | Background | Rowan MP, Cancio LC, Elster EA, Burmeister DM, Rose LF, Natesan S, Chan RK, Christy RJ, Chung KK. Burn wound healing and treatment: review and advancements. Crit Care. 2015 Jun 12;19:243. doi: 10.1186/s13054-015-0961-2. |
| 22571855 | Background | Selig HF, Lumenta DB, Giretzlehner M, Jeschke MG, Upton D, Kamolz LP. The properties of an "ideal" burn wound dressing--what do we need in daily clinical practice? Results of a worldwide online survey among burn care specialists. Burns. 2012 Nov;38(7):960-6. doi: 10.1016/j.burns.2012.04.007. Epub 2012 May 8. |
| 26188898 | Background | Serrano C, Boloix-Tortosa R, Gomez-Cia T, Acha B. Features identification for automatic burn classification. Burns. 2015 Dec;41(8):1883-1890. doi: 10.1016/j.burns.2015.05.011. Epub 2015 Jul 15. |
| 23543513 | Background | Wasiak J, Cleland H, Campbell F, Spinks A. Dressings for superficial and partial thickness burns. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD002106. doi: 10.1002/14651858.CD002106.pub4. |