BurnsPhase 1/2NCT01061502
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
A Phase 1/2 study testing Procellera (Bioelectric Wound Dressing) and Opsite (Transparent Adhesive Dressing) in people with Burns and Wound Healing, run by Vomaris Innovations at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burns, Wound Healing
- What is being tested?
- Procellera (Bioelectric Wound Dressing) and Opsite (Transparent Adhesive Dressing)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2010
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wounds resulting from skin graft
- Split thickness wound
- Wound size greater than 2x2 cm
- Wounds must be ≥5 cm away from all other wounds
- Participant agrees to participate in follow-up evaluation
- Participant must be able to read and understand informed consent, and sign the informed consent
Who cannot join
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
- Participant is to receive another topical antimicrobial agent other than the study dressing
- Participant with sensitivity or adverse reactions to silver or zinc
- Pregnancy or nursing an infant or child
- Immunosuppression
- Active or systemic infection
Show all 12Show fewer
- Peripheral vascular occlusive disease
- Collagen vascular disease
- Connective tissue disease
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites
The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.
- Conditions
- Burns, Wound Healing
- Being tested
- Procellera (Bioelectric Wound Dressing), Opsite (Transparent Adhesive Dressing)
- Keywords
- Burns, Wounds and Injuries, Skin Grafts, Bioelectric, Grafting, skin
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procellera (Bioelectric Wound Dressing)Device
Also called Procellera, PROSIT, Procellera Wound Dressing, Procellera Device
Dressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed
Opsite (Transparent Adhesive Dressing)Device
Also called Opsite Dressing
Semi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed.
| Study group | Role | What they receive |
|---|---|---|
| Procellera Wound Dressing | Experimental | Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed Receives: Device: Procellera (Bioelectric Wound Dressing) |
| Opsite Transparent Adhesive Dressing | Active comparator | Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed Receives: Device: Opsite (Transparent Adhesive Dressing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare epithelialization over time
Measured: 3 months
Secondary outcomes (2)
To compare patient reported perception of pain
Measured: 3 months
To compare scarring
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionNov 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vomaris Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew L Blount, MD, Principal investigator, Blodgett HospitalRichard Wilcox, MD, Study director, Blodgett Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061502
- Sponsor's protocol ID
- XSMP-014
- Status last verified
- Dec 2010
- First submitted
- 1 Feb 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites
- ClinicalTrials.gov ID
- NCT01061502
- Acronym / sponsor ID
- XSMP-014
- Conditions
- Burns, Wound Healing
- Keywords
- Burns, Wounds and Injuries, Skin Grafts, Bioelectric, Grafting, skin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vomaris InnovationsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Feb 2010 (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 whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procellera Wound Dressing | Experimental | Device: Procellera (Bioelectric Wound Dressing)Dressing indicated for partial and full-thickness wounds. Dressing changes every 5-7 days, more frequently if needed |
| Opsite Transparent Adhesive Dressing | Active comparator | Device: Opsite (Transparent Adhesive Dressing)Polyurethane film dressing. Dressing changes every 5-7 days, more frequently if needed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Wounds resulting from skin graft
- Split thickness wound
- Wound size greater than 2x2 cm
- Wounds must be ≥5 cm away from all other wounds
- Participant agrees to participate in follow-up evaluation
Key exclusion criteria (12 listed)
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
- Participant is to receive another topical antimicrobial agent other than the study dressing
- Participant with sensitivity or adverse reactions to silver or zinc
- Pregnancy or nursing an infant or child
- Immunosuppression
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 |
|---|---|---|
| Procellera (Bioelectric Wound Dressing)Also: Procellera, PROSIT, Procellera Wound Dressing, Procellera DeviceDressing used on one-half of the donor graft site. Dressing changes every 5-7 days, more frequently if needed | Device | Procellera Wound Dressing |
| Opsite (Transparent Adhesive Dressing)Also: Opsite DressingSemi-occlusive wound dressing placed on one-half of the skin graft donor site. Dressing change every 5-7 days, more frequently if needed. | Device | Opsite Transparent Adhesive Dressing |
Primary outcome
To compare epithelialization over time
Time frame: 3 months
2 secondary outcomes
To compare patient reported perception of pain
Time frame: 3 months
To compare scarring
Time frame: 3 months
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 10 Dec 2010.
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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.
Andrew L Blount, MD principal investigator
Blodgett Hospital
Richard Wilcox, MD study director
Blodgett Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Procellera (Bioelectric Wound Dressing) and Opsite (Transparent Adhesive Dressing) in people with Burns and Wound Healing, run by Vomaris Innovations 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 12 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 10 Dec 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
To compare epithelialization over time (time frame: 3 months). 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 10 Dec 2010.