HealingPhase 4NCT00727870
Evaluation of Preferences of Consumers and Clinicians for the Management of Shave Biopsy Sites With a PolyMem Formulation Dressing or Current Standard of Care.
A Phase 4 study testing Shapes by PolyMem dressing, Shapes by PolyMem Silver Dressing and Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site in people with Healing, run by Ferris Mfg. Corp. at 1 site in United States.
Trial summary
Shave biopsies are often uncomfortable during the healing process. This is a preliminary study to determine if patients and clinicians prefer using PolyMem formulating dressings on shave biopsy sites compared to the current standard of practice, which is antibiotic ointment covered with a band-aid type dressing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healing
- What is being tested?
- Shapes by PolyMem dressing, Shapes by PolyMem Silver Dressing and Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2012
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals that are going to have two shave biopsies performed on the same day will be evaluated for inclusion in the study.
Who cannot join
- Those that have used systemic corticosteroids in the last three months.
- Those with any medical condition leading to immunosuppression
- Those with a history of keloid formation
- Those with documented compromised wound healing potential
- History of psoriasis or eczema in the last 2 years
- Those with an active infection
Show all 12Show fewer
- Those that use aspirin or non-steroidal anti-inflammatory drugs more than 3 times per week for pain (daily low dose aspirin use for cardiovascular health is not an exclusion criteria)
- Those that have inflammatory conditions such as rheumatoid arthritis or Crohn's disease
- Those that have clinical signs of malnutrition that could interfere with wound healing
- Those that have a history of allergies to any wound dressing or medical tape
- Those that are not able to change the dressing themselves and do not have anyone in their household that can change the dressings if needed.
- Those younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Site, Three Arm, Open Label Comparative Preference Study to Evaluate the Preference of Consumers and Health Care Professionals for the Use of Shapes by PolyMem Wound Dressings and Shapes by PolyMem Silver Wound Dressings, Each Compared to Antibiotic Ointment Covered With a Band-aid Type Dressing (Current Standard of Practice) and to Each Other in the Post-biopsy Management of Shave Biopsies. Each Participant Serves as Own Control. A Blinded Third Party Physician Will Evaluate and Compare the Wounds Based on Photos Taken at the Various Follow-up Points..
Shave biopsies are often uncomfortable during the healing process. This is a preliminary study to determine if patients and clinicians prefer using PolyMem formulating dressings on shave biopsy sites compared to the current standard of practice, which is antibiotic ointment covered with a band-aid type dressing.
Read the detailed description
Only individuals who require 2 shave biopsies on the same treatment day will be entered in the study. Each participant serves as their own control.
- Conditions
- Healing
- Being tested
- Shapes by PolyMem dressing, Shapes by PolyMem Silver Dressing, Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site
- Keywords
- Shave Biopsy management, "Biopsy/adverse effects"[Mesh], "Biopsy/complications"[Mesh])
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shapes by PolyMem dressingDevice
Shapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
Shapes by PolyMem Silver DressingDevice
Shapes by PolyMem Silver dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site
Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second siteDevice
Shapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | After the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem dressing. Receives: Device: Shapes by PolyMem dressing |
| 2 | Other | Arm 2: after the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem Silver dressing. Receives: Device: Shapes by PolyMem Silver Dressing |
| 3 | Other | Arm 3: after the two biopsies, one site will be covered with Shapes by PolyMem dressing and the other site will be covered the Shapes by PolyMem Silver dressing. Receives: Device: Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
Measured: At completion of protocol
Secondary outcomes (1)
Evaluations and comparisons by both treating physician and blinded physician of each site for differences in inflammation, signs of possible infection, reepithelialization and cosmetic appearance
Measured: At completion of protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferris Mfg. Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chicago Skin Clinic, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Andrew M Gorchynsky, MD, Principal investigator, Chicago Skin ClinicDanilo V Del Campo, MD, Principal investigator, Chicago Skin Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727870
- Sponsor's protocol ID
- PolyMem001
- Status last verified
- Mar 2012
- First submitted
- 31 Jul 2008
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site, Three Arm, Open Label Comparative Preference Study to Evaluate the Preference of Consumers and Health Care Professionals for the Use of Shapes by PolyMem Wound Dressings and Shapes by PolyMem Silver Wound Dressings, Each Compared to Antibiotic Ointment Covered With a Band-aid Type Dressing (Current Standard of Practice) and to Each Other in the Post-biopsy Management of Shave Biopsies. Each Participant Serves as Own Control. A Blinded Third Party Physician Will Evaluate and Compare the Wounds Based on Photos Taken at the Various Follow-up Points..
- ClinicalTrials.gov ID
- NCT00727870
- Acronym / sponsor ID
- PolyMem001
- Conditions
- Healing
- Keywords
- Shave Biopsy management, "Biopsy/adverse effects"[Mesh], "Biopsy/complications"[Mesh])
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ferris Mfg. Corp.Industry (pharma, biotech, devices)
- Collaborators
- Chicago Skin Clinic, University of Minnesota
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2012 (estimated)
- First posted
- 4 Aug 2008 (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.
Shave biopsies are often uncomfortable during the healing process. This is a preliminary study to determine if patients and clinicians prefer using PolyMem formulating dressings on shave biopsy sites compared to the current standard of practice, which is antibiotic ointment covered with a band-aid type dressing.
Detailed description
Only individuals who require 2 shave biopsies on the same treatment day will be entered in the study. Each participant serves as their own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Shapes by PolyMem dressingAfter the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem dressing. |
| 2 | Other | Device: Shapes by PolyMem Silver DressingArm 2: after the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem Silver dressing. |
| 3 | Other | Device: Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second siteArm 3: after the two biopsies, one site will be covered with Shapes by PolyMem dressing and the other site will be covered the Shapes by PolyMem Silver dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals that are going to have two shave biopsies performed on the same day will be evaluated for inclusion in the study.
Key exclusion criteria (12 listed)
- Those that have used systemic corticosteroids in the last three months.
- Those with any medical condition leading to immunosuppression
- Those with a history of keloid formation
- Those with documented compromised wound healing potential
- History of psoriasis or eczema in the last 2 years
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 |
|---|---|---|
| Shapes by PolyMem dressingShapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site | Device | 1 |
| Shapes by PolyMem Silver DressingShapes by PolyMem Silver dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site | Device | 2 |
| Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second siteShapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site. | Device | 3 |
Primary outcome
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites.
Time frame: At completion of protocol
1 secondary outcome
Evaluations and comparisons by both treating physician and blinded physician of each site for differences in inflammation, signs of possible infection, reepithelialization and cosmetic appearance
Time frame: At completion of protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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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 M Gorchynsky, MD principal investigator
Chicago Skin Clinic
Danilo V Del Campo, MD principal investigator
Chicago Skin Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shapes by PolyMem dressing, Shapes by PolyMem Silver Dressing and Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site in people with Healing, run by Ferris Mfg. Corp. 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 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Preference by both clinician and consumer of dressing choice in managing shave biopsy sites. (time frame: At completion of protocol). 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 2 Mar 2012.