Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03190655
• Date of registration: 12/06/2017
• Prospective Registration: No
• Primary sponsor: Melva Louisa
• Public title: Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings
• Scientific title: Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings in the Treatment of Partial Thickness Burns
• Date of first enrolment: March 1, 2017
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03190655
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Wawaimuli Arozal, MD, PhD
• Affiliation: Indonesia University

Key inclusion & exclusion 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)



Age minimum: 12 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Partial-thickness Burn

Intervention(s)

Device: Hydrogel

Device: Aluminaid

Primary Outcome(s)

Wound healing [Time Frame: Up to 21 days]

Secondary Outcome(s)

Bullae [Time Frame: at the time of admission up to 30 minutes]

Erythema [Time Frame: at the time of admission up to 30 minutes]

Adverse events [Time Frame: At the time of admission up to 21 days of follow up]

Pain score [Time Frame: At the time of admission up to 30 minutes and 1st week of follow up]

Secondary ID(s)

Aluminaid

Source(s) of Monetary Support

Please refer to primary and secondary sponsors