Acute WoundsPhase 2NCT00816101
Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
A Phase 2 study testing Procellera™ Antimicrobial Dressing, Mepilex® Border Lite and Adhesive Bandage in people with Acute Wounds, run by Vomaris Innovations at 1 site in United States.
Trial summary
The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Wounds
- What is being tested?
- Procellera™ Antimicrobial Dressing, Mepilex® Border Lite and Adhesive Bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2008
- Phase
- Phase 2
- 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 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 1x1 cm
- Wounds 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 14Show fewer
- Peripheral vascular occlusive disease
- Collagen vascular disease
- Connective tissue disease
- Diabetes
- Venous stasis ulcers
- Participant undergoing active cancer chemotherapy
- Chronic steroid use
- Decision impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Sheftel Associates Dermatology
Tucson, Arizona, 85718
About this study
Official title: Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions
The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following curettage and electrodesiccation of skin lesions.
- Conditions
- Acute Wounds
- Being tested
- Procellera™ Antimicrobial Dressing, Mepilex® Border Lite, Adhesive Bandage
- Keywords
- Curettage and electrodesiccation, acute wounds, partial thickness wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procellera™ Antimicrobial DressingOther
Also called PROCELLERA™, Prosit™ Antimicrobial Dressing, Prosit™ Technology
Dressing indicated for partial and full-thickness wounds.
Mepilex® Border LiteOther
Also called Mepilex®
Self-adherent foam dressing
Adhesive BandageDevice
Also called Band-Aid® Adhesive Bandage
Adhesive bandage
| Study group | Role | What they receive |
|---|---|---|
| PROCELLERA™Antimicrobial Dressing | Experimental | Dressing changes every 3 days, more frequently if needed Receives: Other: Procellera™ Antimicrobial Dressing |
| Mepilex® Border Lite | Active comparator | Dressing changes every 2-3 days, more frequently if needed Receives: Other: Mepilex® Border Lite |
| Band-Aid® Adhesive Bandage | Active comparator | Dressing changes every 2-3 days, more frequently if needed. Receives: Device: Adhesive Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experienced 50% or Greater Wound Healing
Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported
Measured: 3 Weeks
Secondary outcomes (2)
Number of Patients Reporting Pain
Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.
Measured: 3 Weeks
Erythema at Week 3
At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with "0" being "No erythema", "1" being "Very slight erythema", "2" being "Well defined erythema", "3" being "Moderate to severe erythema" and 4 being "Severe erythema to slight eschar formation"
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionOct 2008
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 Acute WoundsStudies 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
- 26 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816101
- Sponsor's protocol ID
- XSMP-002
- Status last verified
- Mar 2011
- First submitted
- 21 Oct 2008
- Last updated
- 9 Mar 2011
- 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 Mar 2011. 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 a Curettage and Electrodesiccation of Skin Lesions
- ClinicalTrials.gov ID
- NCT00816101
- Acronym / sponsor ID
- XSMP-002
- Conditions
- Acute Wounds
- Keywords
- Curettage and electrodesiccation, acute wounds, partial thickness wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vomaris InnovationsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Posted 1 Mar 2011
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 pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following 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™Antimicrobial Dressing | Experimental | Other: Procellera™ Antimicrobial DressingDressing changes every 3 days, more frequently if needed |
| Mepilex® Border Lite | Active comparator | Other: Mepilex® Border LiteDressing changes every 2-3 days, more frequently if needed |
| Band-Aid® Adhesive Bandage | Active comparator | Device: Adhesive BandageDressing changes every 2-3 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)
- 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 1x1 cm
- Wounds 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 (14 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 DressingAlso: PROCELLERA™, Prosit™ Antimicrobial Dressing, Prosit™ TechnologyDressing indicated for partial and full-thickness wounds. | Other | PROCELLERA™Antimicrobial Dressing |
| Mepilex® Border LiteAlso: Mepilex®Self-adherent foam dressing | Other | Mepilex® Border Lite |
| Adhesive BandageAlso: Band-Aid® Adhesive BandageAdhesive bandage | Device | Band-Aid® Adhesive Bandage |
Primary outcome
Number of Patients Who Experienced 50% or Greater Wound Healing
Time frame: 3 Weeks
Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported
2 secondary outcomes
Number of Patients Reporting Pain
Time frame: 3 Weeks
Erythema at Week 3
Time frame: 3 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2011.
- 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.
Scott N Sheftel, MD principal investigator
Sheftel Associates Dermatology
1 site 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 Dressing, Mepilex® Border Lite and Adhesive Bandage in people with Acute Wounds, 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 14 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 Mar 2011. 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 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?
Yes. Results are posted in the registry (first posted 1 Mar 2011). 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?
Number of Patients Who Experienced 50% or Greater Wound Healing (time frame: 3 Weeks). 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 Mar 2011.