BurnROMNCT01062191
Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl
A study testing Aquacel AG, typical carboxymethylcellulose dressing and Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing in people with Burn, run by ULURU Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the difference in joint range of motion of a new flexible hydrogel nanoparticle wound dressing compared to typical sodium carboxymethylcellulose dressing Aquacel AG for treatment of partial thickness burns. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn
- What is being tested?
- Aquacel AG, typical carboxymethylcellulose dressing and Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Oct 2008
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female patient is at least 2 years of age;
- Patient is in general good health;
- Patient has partial thickness burn that crosses at least one peripheral joint axial to the proximal interphalangeal joints;
- Patient has one unburned contralateral joint without major internal or external joint derangement to be used as control
- Patient is willing and able to cooperate with the protocol for 30 days
- Patient is capable of provided informed consent
- Patient provides authorization for use and disclosure of protected health information
Who cannot join
- Age less than 2 years;
- Patient has superficial or full thickness burn wounds;
- Patient has acutely infected wounds;
- Patient has wounds with surrounding cellulites;
- Patient has a history of hypersensitivity to any components of either the nanoparticle or sodium hydrocellulose dressing, or any know sensitivities to other hydrogel bandage treatments
- Patient has a concurrent clinical condition, which in the judgment of the Investigator cold either pose a health risk to the patient while participating in this study, or could potentially influence the outcome of the study;
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- Patient is wearing any type of orthopedic device that may come in contact with the dressing;
- Patient has history of poor wound healing, history of smoking, history of drug/alcohol abuse, any other skin/immune system condition that would increase likelihood of wound irritation, infection or increase chance of early termination
- Patient has wound originating from chronic condition
- Patients with history of any immunodeficiency syndrome or condition
- Patients who have applied any dressing or medication (OTC or prescription) to the wound (within 48 hours of study? )
- Patient has participated in a clinical research study within the last 30 days prior to enrollment;
- Patient is unable to communicate or to cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Hydrogel Nanoparticle Wound Dressing Allows Greater Joint Range of Motion Compared to Typical Sodium Carboxymethylcellulose Dressing
The objective of this study is to evaluate the difference in joint range of motion of a new flexible hydrogel nanoparticle wound dressing compared to typical sodium carboxymethylcellulose dressing Aquacel AG for treatment of partial thickness burns.
Read the detailed description
This is a single center, randomized, single blind therapeutic exploratory study to monitor the range of motion of wounds treated with the new nanoparticle hydrogel dressing compared to the range of motion of wounds treated with existing treatment standard (sodium carboxymethylcellulose dressing) in patients with partial thickness burns. A total of 50 joints will be studied. The patients will be at least 7 years of age.. The Department of Physical Medicine and Rehabilitation at Parkland Hospital and Health System, UT Southwestern, will be asked to enroll enough patients to meet the proposed 50 joint study sites (approximately 3-5 afflicted joints per patient). Children will be included in the patient population if possible. Inclusion criteria for the medical condition will be at least one partial thickness burn that crosses at least one peripheral joint axial to the proximal interphalangeal joints. As a control, the patients will also need to have an unburned contralateral joint without major internal or external joint derangement.
The Primary Investigator will first identify the study site and control site for each patient and take the initial measurements. Trained personnel will apply the bandage to the study site. No secondary bandage will be applied. Typical meticulous wound care and adequate analgesic medical coverage will be provided for the duration of the study. Both the patient and medical staff will be trained on patient use instructions for the dressing. The patients will be monitored for a short time after application of the bandage as part of standard procedure, and the patient is then allowed to go home with instructions for care. Within 2-8 days after application, the dressing will be inspected and range of motion will be measured for both the study site and the control site. Any concomitant treatment (medications, wound care) will be thoroughly documented for the duration of the study. Both dressings are designed to remain on the wound until the bandage falls off, which indicates re-epithelialization of the wound. The dressings should not be removed by the patient or medical staff unless there are signs of infection, deterioration of bandage, or other adverse event. If the bandage falls off, the patient is instructed to immediately call the medical staff.
- Conditions
- Burn
- Being tested
- Aquacel AG, typical carboxymethylcellulose dressing, Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing
- Keywords
- hydrogel, dressing, burn, joint
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel AG, typical carboxymethylcellulose dressingDevice
4" X 4", Aquacel silver sheet
Altrazeal Flexible Hydrogel Nanoparticle Wound DressingDevice
Wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing | Experimental | Nanoflex Powder Dressing applied to joint Receives: Device: Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing |
| Aquacel AG, typical carboxymethylcellulose dressing | Active comparator | Sodium CMC dressing control applied to joint Receives: Device: Aquacel AG, typical carboxymethylcellulose dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion in burned joints with dressing in place as compared to control
Measured: Up to 2 weeks
Secondary outcomes (1)
Pain at joint with dressing in place
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startMay 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- ULURU Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062191
- Sponsor's protocol ID
- U-C-6U1101
- Acronym
- ROM
- Status last verified
- Jun 2011
- First submitted
- 2 Feb 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Hydrogel Nanoparticle Wound Dressing Allows Greater Joint Range of Motion Compared to Typical Sodium Carboxymethylcellulose Dressing
- ClinicalTrials.gov ID
- NCT01062191
- Acronym / sponsor ID
- ROM / U-C-6U1101
- Conditions
- Burn
- Keywords
- hydrogel, dressing, burn, joint
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ULURU Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Feb 2010 (estimated)
- 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.
The objective of this study is to evaluate the difference in joint range of motion of a new flexible hydrogel nanoparticle wound dressing compared to typical sodium carboxymethylcellulose dressing Aquacel AG for treatment of partial thickness burns.
Detailed description
This is a single center, randomized, single blind therapeutic exploratory study to monitor the range of motion of wounds treated with the new nanoparticle hydrogel dressing compared to the range of motion of wounds treated with existing treatment standard (sodium carboxymethylcellulose dressing) in patients with partial thickness burns. A total of 50 joints will be studied. The patients will be at least 7 years of age.. The Department of Physical Medicine and Rehabilitation at Parkland Hospital and Health System, UT Southwestern, will be asked to enroll enough patients to meet the proposed 50 joint study sites (approximately 3-5 afflicted joints per patient). Children will be included in the patient population if possible. Inclusion criteria for the medical condition will be at least one partial thickness burn that crosses at least one peripheral joint axial to the proximal interphalangeal joints. As a control, the patients will also need to have an unburned contralateral joint without major internal or external joint derangement.
The Primary Investigator will first identify the study site and control site for each patient and take the initial measurements. Trained personnel will apply the bandage to the study site. No secondary bandage will be applied. Typical meticulous wound care and adequate analgesic medical coverage will be provided for the duration of the study. Both the patient and medical staff will be trained on patient use instructions for the dressing. The patients will be monitored for a short time after application of the bandage as part of standard procedure, and the patient is then allowed to go home with instructions for care. Within 2-8 days after application, the dressing will be inspected and range of motion will be measured for both the study site and the control site. Any concomitant treatment (medications, wound care) will be thoroughly documented for the duration of the study. Both dressings are designed to remain on the wound until the bandage falls off, which indicates re-epithelialization of the wound. The dressings should not be removed by the patient or medical staff unless there are signs of infection, deterioration of bandage, or other adverse event. If the bandage falls off, the patient is instructed to immediately call the medical staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing | Experimental | Device: Altrazeal Flexible Hydrogel Nanoparticle Wound DressingNanoflex Powder Dressing applied to joint |
| Aquacel AG, typical carboxymethylcellulose dressing | Active comparator | Device: Aquacel AG, typical carboxymethylcellulose dressingSodium CMC dressing control applied to joint |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient is at least 2 years of age;
- Patient is in general good health;
- Patient has partial thickness burn that crosses at least one peripheral joint axial to the proximal interphalangeal joints;
- Patient has one unburned contralateral joint without major internal or external joint derangement to be used as control
- Patient is willing and able to cooperate with the protocol for 30 days
Key exclusion criteria (13 listed)
- Age less than 2 years;
- Patient has superficial or full thickness burn wounds;
- Patient has acutely infected wounds;
- Patient has wounds with surrounding cellulites;
- Patient has a history of hypersensitivity to any components of either the nanoparticle or sodium hydrocellulose dressing, or any know sensitivities to other hydrogel bandage treatments
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 |
|---|---|---|
| Aquacel AG, typical carboxymethylcellulose dressing4" X 4", Aquacel silver sheet | Device | Aquacel AG, typical carboxymethylcellulose dressing |
| Altrazeal Flexible Hydrogel Nanoparticle Wound DressingWound dressing | Device | Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing |
Primary outcome
Range of motion in burned joints with dressing in place as compared to control
Time frame: Up to 2 weeks
1 secondary outcome
Pain at joint with dressing in place
Time frame: up to 2 weeks
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquacel AG, typical carboxymethylcellulose dressing and Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing in people with Burn, run by ULURU Inc. at 1 site in United States.
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 7 inclusion and 13 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 8 Jun 2011. 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 United States. 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: Lack of enrollment). 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?
Range of motion in burned joints with dressing in place as compared to control (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2011.