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Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Melva Louisa, Indonesia University

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.


Condition or disease Intervention/treatment Phase
Partial-thickness Burn Device: Aluminaid Device: Hydrogel Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
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.
Primary Purpose: 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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Erythema [ Time Frame: at the time of admission up to 30 minutes ]
    The presence of erythema

  2. Bullae [ Time Frame: at the time of admission up to 30 minutes ]
    The presence of bullae

  3. 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).

  4. 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



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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
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Indonesia
Clinic of Clinical Research Supporting Unit
Jakarta Pusat, Jakarta, Indonesia, 10430
Sponsors and Collaborators
Melva Louisa
Investigators
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Principal Investigator: Wawaimuli Arozal, MD, PhD Indonesia University

Publications:

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Responsible Party: Melva Louisa, Trial Director, Indonesia University
ClinicalTrials.gov Identifier: NCT03190655     History of Changes
Other Study ID Numbers: Aluminaid
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No