Skin Burn Degree SecondPhase 2/3NCT01790763
Compare the Efficacy of Mepilex and Keramatrix in Second Degree Burn Wounds
A Phase 2/3 study testing Keramatrix and Mepilex in people with Skin Burn Degree Second, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Skin Burn Degree Second
- What is being tested?
- Keramatrix and Mepilex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2015
- Phase
- Phase 2/3
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician
Who cannot join
- Patient older than 18
- Causes other than flame or scald injuries (ie.chemical or frostbite)
- Wounds noted to be contaminated or infected
- Patients who have received previous treatment efforts (topical dressings or previous wound debridement)
- Pregnancy lactation
- Co-morbidity which may compromise healing: known history of AIDS, ARC, HIV, cancer, autoimmune diseases,cirrhosis, tuberculosis, chronic glucocorticoid therapy, diabetes mellitus, renal insufficiency, hepatic disease, congestive heart failure prior to burn injury, associated severe head injury requiring specific treatment
- known allergy to sheep's wool
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Galveston, Texas, 77551
About this study
Official title: Prospective,Randomized, Parallel Study to Compare the Efficacy of Mepilex and Keramatrix in Promoting Healing of Second Degree Burn Wounds
The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.
Read the detailed description
Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.
- Conditions
- Skin Burn Degree Second
- Being tested
- Keramatrix, Mepilex
- Keywords
- Burn, Second-degree
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeramatrixDevice
Dressing for second degree burn
MepilexDevice
Dressing for second degree wound
| Study group | Role | What they receive |
|---|---|---|
| Keramatrix | Active comparator | Keramatrix Receives: Device: Keramatrix |
| Mepilex | Active comparator | Mepilex Receives: Device: Mepilex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Wound healing will be determined by measuring wound surface area. Wound surface area will be determined through planimetry, which will be performed on digital photographs of the wounds.
Measured: Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals
Secondary outcomes (3)
Infection rates
Subjects will be monitored for unusual occurences, including signs and symptoms of infection.
Measured: Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals
Scarring
Scarring will be evaluated using the Vancouver Clinical Scar Scale. Assessments of graft pigmentation, vascularity, pliability and height will be performed at follow-up visits.
Measured: 52 weeks up to 78 weeks
Pain
Pain will be assessed using pain scales according to age.
Measured: duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals, up to 3 times a week during dressing changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Due to lack of funding from the sponsor this study is being withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Burn Degree SecondStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Keraplast Technologies, LLC, Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- Carlos Jimenez, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790763
- Sponsor's protocol ID
- 12-203
- Status last verified
- May 2015
- First submitted
- 13 Nov 2012
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective,Randomized, Parallel Study to Compare the Efficacy of Mepilex and Keramatrix in Promoting Healing of Second Degree Burn Wounds
- ClinicalTrials.gov ID
- NCT01790763
- Acronym / sponsor ID
- 12-203
- Conditions
- Skin Burn Degree Second
- Keywords
- Burn, Second-degree
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to lack of funding from the sponsor this study is being withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Keraplast Technologies, LLC, Shriners Hospitals for Children
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Feb 2013 (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 purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.
Detailed description
Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keramatrix | Active comparator | Device: KeramatrixKeramatrix |
| Mepilex | Active comparator | Device: MepilexMepilex |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician
Key exclusion criteria (7 listed)
- Patient older than 18
- Causes other than flame or scald injuries (ie.chemical or frostbite)
- Wounds noted to be contaminated or infected
- Patients who have received previous treatment efforts (topical dressings or previous wound debridement)
- Pregnancy lactation
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 |
|---|---|---|
| KeramatrixDressing for second degree burn | Device | Keramatrix |
| MepilexDressing for second degree wound | Device | Mepilex |
Primary outcome
Wound Healing
Time frame: Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals
Wound healing will be determined by measuring wound surface area. Wound surface area will be determined through planimetry, which will be performed on digital photographs of the wounds.
3 secondary outcomes
Infection rates
Time frame: Duration of hospital stay, an expected average of 0.75 days per percent burn until wound heals
Scarring
Time frame: 52 weeks up to 78 weeks
Pain
Time frame: duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals, up to 3 times a week during dressing changes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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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.
Carlos Jimenez, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Keramatrix and Mepilex in people with Skin Burn Degree Second, run by The University of Texas Medical Branch, Galveston 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 May 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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: Duration of hospital stay, an expected average of 0.75 days per every percent burn until wound heals). 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 14 May 2015.