Wound HealingPhase 2NCT01004055
Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
A Phase 2 study testing Procellera™ Antimicrobial Wound Dressing, ACTICOAT™ Antimicrobial Barrier Dressing and Mepilex® Ag Silver Foam Dressing in people with Wound Healing and Wound Infection, run by Vomaris Innovations at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wound Healing, Wound Infection
- What is being tested?
- Procellera™ Antimicrobial Wound Dressing, ACTICOAT™ Antimicrobial Barrier Dressing and Mepilex® Ag Silver Foam Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Oct 2009
- Phase
- Phase 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
- If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test
- Wound size greater than 1x1cm
- Wound must be ≥5 cm away from all other wounds
- Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
- 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
- Collagen vascular disease
- Diabetes
- Venous stasis ulcers
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sheftel Associates Dermatology, LLC
Oro Valley, Arizona, 85755
Sheftel Associates Dermatology, LLC
Tucson, Arizona, 85718
About this study
Official title: Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions
The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.
- Conditions
- Wound Healing, Wound Infection
- Being tested
- Procellera™ Antimicrobial Wound Dressing, ACTICOAT™ Antimicrobial Barrier Dressing, Mepilex® Ag Silver Foam Dressing
- Keywords
- Wound, Skin lesion, Antimicrobial, Bioelectric
- Medical subject headings
- Wound Infection, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procellera™ Antimicrobial Wound DressingDevice
Also called PROCELLERA™, PROSIT™, Bioelectric Wound Dressing
Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed
ACTICOAT™ Antimicrobial Barrier DressingDrug
Also called ACTICOAT™
Dressing changes every 2-3 days, more frequently if needed
Mepilex® Ag Silver Foam DressingDrug
Also called Mepilex® Ag
Dressing changes every 2-3 days, more frequently if needed
| Study group | Role | What they receive |
|---|---|---|
| Procellera™ Wound Dressing | Experimental | Not described Receives: Device: Procellera™ Antimicrobial Wound Dressing |
| ACTICOAT™ | Active comparator | Not described Receives: Drug: ACTICOAT™ Antimicrobial Barrier Dressing |
| Mepilex® Ag | Active comparator | Not described Receives: Drug: Mepilex® Ag Silver Foam Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing over time
Measured: July 2008-October 2009
Secondary outcomes (1)
Comparing three FDA cleared products for pain reduction and incidence of infection
Measured: July 2008-October 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vomaris Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott N Sheftel, MD, Principal investigator, Sheftel Associates Dermatology, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004055
- Sponsor's protocol ID
- XSMP-011
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. 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 Wounds After Curettage and Electrodesiccation of Skin Lesions
- ClinicalTrials.gov ID
- NCT01004055
- Acronym / sponsor ID
- XSMP-011
- Conditions
- Wound Healing, Wound Infection
- Keywords
- Wound, Skin lesion, Antimicrobial, Bioelectric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vomaris InnovationsIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 29 Oct 2009 (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 a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Procellera™ Wound Dressing | Experimental | Device: Procellera™ Antimicrobial Wound Dressing |
| ACTICOAT™ | Active comparator | Drug: ACTICOAT™ Antimicrobial Barrier Dressing |
| Mepilex® Ag | Active comparator | Drug: Mepilex® Ag Silver Foam Dressing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test
- Wound size greater than 1x1cm
- Wound must be ≥5 cm away from all other wounds
- Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
- 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™ Antimicrobial Wound DressingAlso: PROCELLERA™, PROSIT™, Bioelectric Wound DressingDressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed | Device | Procellera™ Wound Dressing |
| ACTICOAT™ Antimicrobial Barrier DressingAlso: ACTICOAT™Dressing changes every 2-3 days, more frequently if needed | Drug | ACTICOAT™ |
| Mepilex® Ag Silver Foam DressingAlso: Mepilex® AgDressing changes every 2-3 days, more frequently if needed | Drug | Mepilex® Ag |
Primary outcome
Wound healing over time
Time frame: July 2008-October 2009
1 secondary outcome
Comparing three FDA cleared products for pain reduction and incidence of infection
Time frame: July 2008-October 2009
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 29 Oct 2009.
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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.
Scott N Sheftel, MD principal investigator
Sheftel Associates Dermatology, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Procellera™ Antimicrobial Wound Dressing, ACTICOAT™ Antimicrobial Barrier Dressing and Mepilex® Ag Silver Foam Dressing in people with Wound Healing and Wound Infection, run by Vomaris Innovations at 2 sites 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 29 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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?
Wound healing over time (time frame: July 2008-October 2009). 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 29 Oct 2009.