BurnsNCT00581217
A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings
An observational study of Burns, run by University of California, Irvine at 1 site in United States.
Trial summary
The research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Aquacel Ag and Glucan II
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Sep 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Burn injured patients or patients who have had full thickness skin loss requiring skin grafting and donor site dressings
Who may be able to join
- Adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting
Who cannot join
- Individuals under the age of 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine Medical Center
Orange, California, 92868
About this study
Official title: A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings With Regards to Healing Time, Cosmesis, Infection Rate, and Patient's Perceived Pain: a Pilot Study.
The research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag.
- Conditions
- Burns
- Being tested
- Aquacel Ag, Glucan II
- Keywords
- Burn injury, Skin graft, Donor site dressing, Outcomes, Infection rate, Healing time, Cosmetic Result, Pain, Burn injured patients requiring skin grafting
- Medical subject headings
- Burns, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel AgOther
Aquacel Ag will be applied to one donor site.
Glucan IIOther
Glucan II to be applied to a donor site on same patient for comparison
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Burn patients or patients with skin loss requiring split-thickness skin graft Receives: Other: Aquacel Ag; Other: Glucan II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Measured: 7 - 14 days
Secondary outcomes (3)
Infection rate
Measured: 1-21 days
Cosmetic outcome
Measured: 6 months
Pain rating
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionSep 2010
Why it stopped: Study Investigator has suddenly died, study has no results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianne E Cinat, MD, Principal investigator, University of California, IrvineSuzanne Bailey, PT, Principal investigator, University of California, IrvineMelissa Carmean, PT, CWS, BS, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581217
- Sponsor's protocol ID
- 2006-4881
- Status last verified
- Jul 2018
- First submitted
- 21 Dec 2007
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings With Regards to Healing Time, Cosmesis, Infection Rate, and Patient's Perceived Pain: a Pilot Study.
- ClinicalTrials.gov ID
- NCT00581217
- Acronym / sponsor ID
- 2006-4881
- Conditions
- Burns
- Keywords
- Burn injury, Skin graft, Donor site dressing, Outcomes, Infection rate, Healing time, Cosmetic Result, Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study Investigator has suddenly died, study has no results.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Dec 2007 (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 research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | – | Other: Aquacel Ag, Other: Glucan IIBurn patients or patients with skin loss requiring split-thickness skin graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Burn injured patients or patients who have had full thickness skin loss requiring skin grafting and donor site dressings
Key inclusion criteria (1 listed)
- Adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting
Key exclusion criteria (1 listed)
- Individuals under the age of 18.
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 AgAquacel Ag will be applied to one donor site. | Other | Single arm study |
| Glucan IIGlucan II to be applied to a donor site on same patient for comparison | Other | Single arm study |
Primary outcome
Healing time
Time frame: 7 - 14 days
3 secondary outcomes
Infection rate
Time frame: 1-21 days
Cosmetic outcome
Time frame: 6 months
Pain rating
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study Investigator has suddenly died, study has no results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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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.
Marianne E Cinat, MD principal investigator
University of California, Irvine
Suzanne Bailey, PT principal investigator
University of California, Irvine
Melissa Carmean, PT, CWS, BS principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by University of California, Irvine 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 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: stopped early, as of the sponsor's last update on 23 Jul 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 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: Study Investigator has suddenly died, study has no results.). 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?
Healing time (time frame: 7 - 14 days). 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 23 Jul 2018.