BurnPhase 2/3AmnionNCT00674999
Use of Amnion on Partial Thickness Burns
A Phase 2/3 study testing Amnion and Polysporin/Bacitracin/Mycostatin in people with Burn, run by The University of Texas Medical Branch, Galveston.
Trial summary
To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burn
- What is being tested?
- Amnion and Polysporin/Bacitracin/Mycostatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Sep 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Partial thickness burn injury.
- >2% burn injury.
- Ages 0-100 years.
Who cannot join
- Patients not expected to survive
About this study
Official title: Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications
To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.
- Conditions
- Burn
- Being tested
- Amnion, Polysporin/Bacitracin/Mycostatin
- Keywords
- Burn, Partial thickness burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnionBiological
Application of Amnion with processing procedures involving the use of trypsin-EDTA
AmnionBiological
Application of Amnion with processing procedures involving the use of Dispase II
Polysporin/Bacitracin/MycostatinDrug
Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA) Receives: Biological: Amnion |
| 2 | Experimental | Amnion with processing procedures involving the use of Dispase II Receives: Biological: Amnion |
| 3 | Active comparator | Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin Receives: Drug: Polysporin/Bacitracin/Mycostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time to 95% healing of treated burn wounds
Measured: Assessment daily until 95 % healed
Secondary outcomes (4)
Length of hospital stay
Measured: Measured at hospital discharge
Incidence of infection
Measured: Measure daily until complete wound healing
Amount of daily pain until wound is healed with different treatments.
Measured: Daily until wound is completely healed.
Amount of scaring with different treatments
Measured: From injury to 2 years post burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJun 2005
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Hurricane- terminated study due to skin bank being destroyed
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.
- 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
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674999
- Sponsor's protocol ID
- 05-040
- Acronym
- Amnion
- Status last verified
- Nov 2012
- First submitted
- 26 Dec 2007
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications
- ClinicalTrials.gov ID
- NCT00674999
- Acronym / sponsor ID
- Amnion / 05-040
- Conditions
- Burn
- Keywords
- Burn, Partial thickness burn
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hurricane- terminated study due to skin bank being destroyed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 May 2008 (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.
To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: AmnionAmnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA) |
| 2 | Experimental | Biological: AmnionAmnion with processing procedures involving the use of Dispase II |
| 3 | Active comparator | Drug: Polysporin/Bacitracin/MycostatinPrepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Partial thickness burn injury.
- >2% burn injury.
- Ages 0-100 years.
Key exclusion criteria (1 listed)
- Patients not expected to survive
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 |
|---|---|---|
| AmnionApplication of Amnion with processing procedures involving the use of trypsin-EDTA | Biological | 1 |
| AmnionApplication of Amnion with processing procedures involving the use of Dispase II | Biological | 2 |
| Polysporin/Bacitracin/MycostatinApplication of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined | Drug | 3 |
Primary outcome
Length of time to 95% healing of treated burn wounds
Time frame: Assessment daily until 95 % healed
4 secondary outcomes
Length of hospital stay
Time frame: Measured at hospital discharge
Incidence of infection
Time frame: Measure daily until complete wound healing
Amount of daily pain until wound is healed with different treatments.
Time frame: Daily until wound is completely healed.
Amount of scaring with different treatments
Time frame: From injury to 2 years post burn
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 15 Nov 2012.
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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.
David N Herndon, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amnion and Polysporin/Bacitracin/Mycostatin in people with Burn, run by The University of Texas Medical Branch, Galveston.
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 3 inclusion and 1 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 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Length of time to 95% healing of treated burn wounds (time frame: Assessment daily until 95 % healed). 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 15 Nov 2012.