BurnsNCT00137163
Evaluation of Dermafill Dressing for Donor Sites
A study testing Dermafill Dressing in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
The purpose of the study is to compare one type of dressing against the current standard dressing that is used to cover the unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Dermafill Dressing
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older; male or female.
- Burn wounds less than 30% of total body surface area (TBSA) with no systemic abnormalities
- Burns do not involve the harvesting area
- Burn wounds require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
- Scheduled excision and grafting procedure is the first such operation for subject during this hospitalization
- Subject agrees to participate in follow-up evaluations
Who cannot join
- Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
- Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep venous thrombosis (DVT) prophylaxis.
- Cellulitis or other infection of potential donor site
- Previously harvested donor site
- Subjects with greater than 30% TBSA burns
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234-6315
About this study
Official title: Evaluation of Dermafill Dressing for Autogenous Skin Donor Sites
The purpose of the study is to compare one type of dressing against the current standard dressing that is used to cover the unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.
Hypothesis: The mean healing time for wounds treated with the Dermafill dressing will be less than the mean healing time for wounds treated with Xeroform dressing.
Read the detailed description
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. The donor sites will be harvested. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Dermafill dressing or Xeroform. The wound dressings will then be observed at least once a day beginning post op day 2/48hours after surgery until healed, which is defined as 90% or more of the wound surface is confluently re-epithelized.
- Conditions
- Burns
- Being tested
- Dermafill Dressing
- Keywords
- burns, donor site care, Dermafill dressing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermafill DressingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be less or equal to with the Dermafill dressing as compared with Xeroform
Cosmetic effect of healing at post surgery day 30-60 will be equal or less with Dermafill as compared with Xeroform
Secondary outcomes (1)
Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startMar 2005
- Primary completionJan 2007
- Study completionMar 2007
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Investigators
- Michael Albrecht, MD, Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137163
- Sponsor's protocol ID
- H-04-026
- Status last verified
- Jul 2008
- First submitted
- 25 Aug 2005
- Last updated
- 28 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dermafill Dressing for Autogenous Skin Donor Sites
- ClinicalTrials.gov ID
- NCT00137163
- Acronym / sponsor ID
- H-04-026
- Conditions
- Burns
- Keywords
- burns, donor site care, Dermafill dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Mar 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 29 Aug 2005 (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 the study is to compare one type of dressing against the current standard dressing that is used to cover the unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.
Hypothesis: The mean healing time for wounds treated with the Dermafill dressing will be less than the mean healing time for wounds treated with Xeroform dressing.
Detailed description
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. The donor sites will be harvested. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Dermafill dressing or Xeroform. The wound dressings will then be observed at least once a day beginning post op day 2/48hours after surgery until healed, which is defined as 90% or more of the wound surface is confluently re-epithelized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older; male or female.
- Burn wounds less than 30% of total body surface area (TBSA) with no systemic abnormalities
- Burns do not involve the harvesting area
- Burn wounds require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
- Scheduled excision and grafting procedure is the first such operation for subject during this hospitalization
Key exclusion criteria (7 listed)
- Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
- Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep venous thrombosis (DVT) prophylaxis.
- Cellulitis or other infection of potential donor site
- Previously harvested donor site
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 |
|---|---|---|
| Dermafill Dressing | Device | – |
Primary outcome
Pain will be less or equal to with the Dermafill dressing as compared with Xeroform
Cosmetic effect of healing at post surgery day 30-60 will be equal or less with Dermafill as compared with Xeroform
1 secondary outcome
Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2008.
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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.
Michael Albrecht, MD principal investigator
US Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermafill Dressing in people with Burns, run by United States Army Institute of Surgical Research 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 6 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: finished, as of the sponsor's last update on 28 Jul 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain will be less or equal to with the Dermafill dressing as compared with Xeroform. The study lists 2 primary outcomes in all. 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 28 Jul 2008.