Partial-thickness BurnNCT03190655
Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings
A study testing Aluminaid and Hydrogel in people with Partial-thickness Burn, run by Melva Louisa at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Partial-thickness Burn
- What is being tested?
- Aluminaid and Hydrogel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2017to 5 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Clinic of Clinical Research Supporting Unit
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: 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.
Read the 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.
- Conditions
- Partial-thickness Burn
- Being tested
- Aluminaid, Hydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AluminaidDevice
Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium
HydrogelDevice
Hydrogel based wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Aluminaid | Experimental | Treatment group: Aluminaid wound dressing Receives: Device: Aluminaid |
| Hydrogel | Active comparator | Hydrogel wound dressing (Trademark: Burnshield) Receives: Device: Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Wound healing as determine by the time of complete re-epithelization of the study area, in days.
Measured: Up to 21 days
Secondary outcomes (4)
Erythema
The presence of erythema
Measured: at the time of admission up to 30 minutes
Bullae
The presence of bullae
Measured: 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).
Measured: 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
Measured: At the time of admission up to 21 days of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Mar 2017
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Why it stopped: Stopped by the Sponsor due to their change in product development priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Partial-thickness BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melva Louisa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melva Louisa, Universitas Indonesia
- Investigators
- Wawaimuli Arozal, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190655
- Sponsor's protocol ID
- Aluminaid
- Status last verified
- Mar 2018
- First submitted
- 12 Jun 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20079572Cancio 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.
PubMed 22850157Hettiaratchy 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.
PubMed 15191982Lars 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.
PubMed 24563639Rowan 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.
PubMed 26067660Selig 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.
PubMed 22571855Serrano 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.
PubMed 26188898Wasiak 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.
PubMed 23543513
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings in the Treatment of Partial Thickness Burns
- ClinicalTrials.gov ID
- NCT03190655
- Acronym / sponsor ID
- Aluminaid
- Conditions
- Partial-thickness Burn
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped by the Sponsor due to their change in product development priorities.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Melva LouisaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Aluminaid | Experimental | Device: AluminaidTreatment group: Aluminaid wound dressing |
| Hydrogel | Active comparator | Device: HydrogelHydrogel wound dressing (Trademark: Burnshield) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AluminaidAluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium | Device | Aluminaid |
| HydrogelHydrogel based wound dressing | Device | Hydrogel |
Primary outcome
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.
4 secondary outcomes
Erythema
Time frame: at the time of admission up to 30 minutes
Bullae
Time frame: at the time of admission up to 30 minutes
Pain score
Time frame: At the time of admission up to 30 minutes and 1st week of follow up
Adverse events
Time frame: At the time of admission up to 21 days of follow up
Results and safety
The study was stopped early (reason given: Stopped by the Sponsor due to their change in product development priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Background: PubMed 20079572Grippaudo 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.
- Background: PubMed 22850157Cancio 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.
- Background: PubMed 15191982Hettiaratchy 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.
- Background: PubMed 24563639Lars 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.
- Background: PubMed 26067660Rowan 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.
- Background: PubMed 22571855Selig 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.
- Background: PubMed 26188898Serrano 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.
- Background: PubMed 23543513Wasiak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wawaimuli Arozal, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aluminaid and Hydrogel in people with Partial-thickness Burn, run by Melva Louisa at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped by the Sponsor due to their change in product development priorities.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03190655, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.