Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings

NCT03190655 | Terminated

• 1 other identifier: Aluminaid
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial-thickness Burn

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Wound healing as determine by the time of complete re-epithelization of the study area, in days.

  Up to 21 days

Secondary Outcomes (4)

• Erythema

  at the time of admission up to 30 minutes

• Bullae

  at the time of admission up to 30 minutes

• Pain score

  At the time of admission up to 30 minutes and 1st week of follow up

• Adverse events

  At the time of admission up to 21 days of follow up

Study Arms (2)

Aluminaid

EXPERIMENTAL

Treatment group: Aluminaid wound dressing

Device: Aluminaid

Hydrogel

ACTIVE COMPARATOR

Hydrogel wound dressing (Trademark: Burnshield)

Device: Hydrogel

Interventions

Aluminaid DEVICE

Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium

Aluminaid

Hydrogel DEVICE

Hydrogel based wound dressing

Hydrogel

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Melva Louisa: lead

Study Sites (1)

Clinic of Clinical Research Supporting Unit

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (8)

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  PMID: 20079572 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.

  PMID: 22850157 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.

  PMID: 15191982 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.

  PMID: 24563639 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.

  PMID: 26067660 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.

  PMID: 22571855 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.

  PMID: 26188898 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.

  PMID: 23543513 BACKGROUND

MeSH Terms

Interventions

Bandages, Hydrocolloid

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Wawaimuli Arozal, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trial Director

Model Details: Patients who attend the clinical sites, presenting with untreated partial thickness burns less than 4 hours, and meet the inclusion and exclusion criteria

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 19, 2017
• Study Start: March 1, 2017
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)