Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings

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

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.

Study Overview

• Status: Terminated
• Conditions: Partial-thickness Burn
• Intervention / Treatment: Device: Aluminaid; Device: Hydrogel

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Clinic of Clinical Research Supporting Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 61 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Melva Louisa
• Investigators: Principal Investigator: Wawaimuli Arozal, MD, PhD, Indonesia University

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: BMJ. 2004 Jul 17;329(7458):148.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): March 5, 2018
• Study Completion (Actual): March 5, 2018

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Aluminaid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No