BurnsNCT01268189
Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
A study testing Oxygen diffusing dressing in people with Burns, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing (Xeroform). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Oxygen diffusing dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must be at least 18 years of age; of either gender and in good general health.
- Subject has sustained burn wounds of less than 30 percent of the total body surface area
- Burn wounds do not involve the harvesting area
- Subject has sustained burn wounds that, in the judgment of the attending surgeon, require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surfaces areas
- The scheduled excision and grafting procedure is the first such operation for the subject during this hospitalization
- Subject agrees to participate in follow-up evaluations
Who cannot join
- Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 or requiring vasoactive medications to support blood pressure
- Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subjects receiving treatment with medications that inhibit or compromise wound healing. Examples include therapeutic anticoagulants, antiplatelet drugs, and systemic steroids such as warfarin, clopidogrel or prednisone. The use of anticoagulants does not include DVT (Deep Vein Thrombosis) prophylaxis. Subjects may use aspirin or lovenox
- Cellulitis or other infection of the potential donor sites
- Donor site has been previously harvested for grafting
- Subjects with greater than 30% total body surface area burns
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research, Burn Center
Fort Sam Houston, Texas, 78234
About this study
This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean healing time for wounds treated with the OxyBand dressing will be less than the mean healing time for wounds treated with the Xeroform dressing.
Read the detailed description
Patients who are scheduled for excision of burns or other injuries will have one of two donor sites covered with the OxyBand Dressing, and the other treated according to standard of care. OxyBand is an FDA (Food and Drug Administration) approved (K043063) wound dressing for delivery of oxygen into the wound. Two small clinical studies using OxyBand have been conducted on standardized laser burn wounds, demonstrating faster healing time compared to a placebo. No studies have compared this dressing to Xeroform dressing, the standard dressing used on donor sites in the USAISR.
- Conditions
- Burns
- Being tested
- Oxygen diffusing dressing, Standard of care dressing
- Keywords
- burn wound, management with oxygen
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen diffusing dressingDevice
Also called OxyBand dressing
Oxygen diffusing dressing applied to study wound
Standard of care dressingDevice
Also called Xeroform dressing
Xeroform control dressing applied to control wound
| Study group | Role | What they receive |
|---|---|---|
| Burn wound patients with donor sites | Experimental | Oxygen diffusing dressing applied to wound vs standard of care dressing (Xeroform) applied to wound (patient serves as own control as s/he receives 1 dressing on 1 donor site and the other on a 2nd donor site) Receives: Device: Oxygen diffusing dressing; Device: Standard of care dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Time for Donor Site Wounds
Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.
Measured: number of days to healing
Secondary outcomes (4)
Pain Perceived by Patient
Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.
Measured: Post-Operative Day 4
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Measured: Post-Operative Day 8
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Measured: Post-Operative Day 10
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Measured: Post-Operative Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kimberly F Lairet, MD, Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268189
- Sponsor's protocol ID
- H-09-008
- Status last verified
- Sep 2015
- First submitted
- 21 Dec 2010
- Last updated
- 9 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
- ClinicalTrials.gov ID
- NCT01268189
- Acronym / sponsor ID
- H-09-008
- Conditions
- Burns
- Keywords
- burn wound, management with oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Posted 9 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean healing time for wounds treated with the OxyBand dressing will be less than the mean healing time for wounds treated with the Xeroform dressing.
Detailed description
Patients who are scheduled for excision of burns or other injuries will have one of two donor sites covered with the OxyBand Dressing, and the other treated according to standard of care. OxyBand is an FDA (Food and Drug Administration) approved (K043063) wound dressing for delivery of oxygen into the wound. Two small clinical studies using OxyBand have been conducted on standardized laser burn wounds, demonstrating faster healing time compared to a placebo. No studies have compared this dressing to Xeroform dressing, the standard dressing used on donor sites in the USAISR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn wound patients with donor sites | Experimental | Device: Oxygen diffusing dressing, Device: Standard of care dressingOxygen diffusing dressing applied to wound vs standard of care dressing (Xeroform) applied to wound (patient serves as own control as s/he receives 1 dressing on 1 donor site and the other on a 2nd donor site) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be at least 18 years of age; of either gender and in good general health.
- Subject has sustained burn wounds of less than 30 percent of the total body surface area
- Burn wounds do not involve the harvesting area
- Subject has sustained burn wounds that, in the judgment of the attending surgeon, require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surfaces areas
- The scheduled excision and grafting procedure is the first such operation for the subject during this hospitalization
Key exclusion criteria (8 listed)
- Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 or requiring vasoactive medications to support blood pressure
- Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subjects receiving treatment with medications that inhibit or compromise wound healing. Examples include therapeutic anticoagulants, antiplatelet drugs, and systemic steroids such as warfarin, clopidogrel or prednisone. The use of anticoagulants does not include DVT (Deep Vein Thrombosis) prophylaxis. Subjects may use aspirin or lovenox
- Cellulitis or other infection of the potential donor sites
- Donor site has been previously harvested for grafting
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 |
|---|---|---|
| Oxygen diffusing dressingAlso: OxyBand dressingOxygen diffusing dressing applied to study wound | Device | Burn wound patients with donor sites |
| Standard of care dressingAlso: Xeroform dressingXeroform control dressing applied to control wound | Device | Burn wound patients with donor sites |
Primary outcome
Healing Time for Donor Site Wounds
Time frame: number of days to healing
Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.
4 secondary outcomes
Pain Perceived by Patient
Time frame: Post-Operative Day 4
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Time frame: Post-Operative Day 8
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Time frame: Post-Operative Day 10
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Time frame: Post-Operative Day 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kimberly F Lairet, 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 Oxygen diffusing 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 8 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 9 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 for Donor Site Wounds (time frame: number of days to healing). 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 9 Oct 2015.