Skin Flora InfectionPhase 1NCT01368120
Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth
A Phase 1 study testing IV Clear™ Dressing and Tegaderm CHG™ in people with Skin Flora Infection, run by Covalon Technologies Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Flora Infection
- What is being tested?
- IV Clear™ Dressing and Tegaderm CHG™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are ≥ 18 years of age and ≤ 65 years of age
- Are in good health, as evidenced by response to the demographics/dermatological medical history form
- Are willing to refrain from using antimicrobial soaps for bathing and showering during the entire study
- Are willing to refrain from swimming in chemically treated pool or hot tub for duration of study
- Are willing to refrain from using antimicrobial/medicated lotions and creams for duration of study, unless prescribed by a physician for an intercurrent illness
- Are willing to refrain from using topical or systemic antibiotic medication for duration of study, unless prescribed by a physician for an intercurrent illness
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- Are willing to refrain from use of body powders and fabric softeners
- Are willing to use soap and shampoo and antiperspirant/deodorant provided exclusively during study
- Have qualification screening bacterial counts of ≥ 2.5 log10 CFU/cm² on two contralateral sites on the upper back
- Are willing to comply with all study protocol requirements
Who cannot join
- Subjects will not be enrolled in the study if they:
- Are currently pregnant or lactating
- Have been exposed to topical or systemic antimicrobials during two weeks proceeding treatment. This restriction will include, but is not limited to shampoos, lotions, soaps, body powders, and materials such as solvents, acids, or alkalis
- Have known soap, detergent, antibiotic and/or perfume allergies
- Have been medically diagnosed as having a medical condition that precludes participation, such as: diabetes, hepatitis, an organ transplant, a medical surgical implant or an immune compromised system
- Have any medical condition which in the opinion of the Investigator prelude participation
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- Have swam in chemically treated pools or hot tubs two weeks prior to any microbial sampling
- Have used UV tanning lamps two weeks prior to any microbial sampling
- Have tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders on test sites
- Have bathed or showered less than 48 hours prior to any microbial sampling
- Have known sensitivity to adhesive products, or to materials used in test articles
- Have participated in any type of back wash study within 7 days prior to study
- Have a known sensitivity to latex products
- Are not willing to fulfill the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.
Read the detailed description
A single center, within-subject randomized study design in healthy adult subjects with a history of high bacteria counts on their upper back, meeting the inclusion criteria.
Antimicrobial efficacy will be measured by determining the mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement), following preparation with 70% isopropyl alcohol, and following post treatment samples.
The goal of this study is to demonstrate that IV Clear™ is as effective as or better than Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.
- Conditions
- Skin Flora Infection
- Being tested
- IV Clear™ Dressing, Tegaderm CHG™, Silicone Vehicle Control Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Clear™ DressingDevice
Polyurethane film, silicone adhesive dressing with chlorhexidine and silver
Tegaderm CHG™Device
Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
Silicone Vehicle Control DressingDevice
Polyurethane film with silicone adhesive dressing, without antimicrobials
| Study group | Role | What they receive |
|---|---|---|
| IV Clear™ | Experimental | Not described Receives: Device: IV Clear™ Dressing |
| Tegaderm CHG™ | Active comparator | Not described Receives: Device: Tegaderm CHG™ |
| Vehicle Control Dressing | Placebo comparator | Not described Receives: Device: Silicone Vehicle Control Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin microbial colonization over 7-day period of antimicrobial dressing application
Mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline), following prepping with 70% isopropyl alcohol and following post treatment samplings of IV Clear™, Tegaderm™ CHG and Silicone control dressings collected.
Measured: Assessed after 4 days and 7 days of dressing application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Flora InfectionStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Covalon Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis J Ward, D.O., Principal investigator, Hill Top Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368120
- Sponsor's protocol ID
- TP-014
- Status last verified
- Apr 2015
- First submitted
- 6 Jun 2011
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth
- ClinicalTrials.gov ID
- NCT01368120
- Acronym / sponsor ID
- TP-014
- Conditions
- Skin Flora Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Covalon Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Jun 2011 (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 assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.
Detailed description
A single center, within-subject randomized study design in healthy adult subjects with a history of high bacteria counts on their upper back, meeting the inclusion criteria.
Antimicrobial efficacy will be measured by determining the mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement), following preparation with 70% isopropyl alcohol, and following post treatment samples.
The goal of this study is to demonstrate that IV Clear™ is as effective as or better than Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV Clear™ | Experimental | Device: IV Clear™ Dressing |
| Tegaderm CHG™ | Active comparator | Device: Tegaderm CHG™ |
| Vehicle Control Dressing | Placebo comparator | Device: Silicone Vehicle Control Dressing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Are ≥ 18 years of age and ≤ 65 years of age
- Are in good health, as evidenced by response to the demographics/dermatological medical history form
- Are willing to refrain from using antimicrobial soaps for bathing and showering during the entire study
- Are willing to refrain from swimming in chemically treated pool or hot tub for duration of study
- Are willing to refrain from using antimicrobial/medicated lotions and creams for duration of study, unless prescribed by a physician for an intercurrent illness
Key exclusion criteria (14 listed)
- Are currently pregnant or lactating
- Have been exposed to topical or systemic antimicrobials during two weeks proceeding treatment. This restriction will include, but is not limited to shampoos, lotions, soaps, body powders, and materials such as solvents, acids, or alkalis
- Have known soap, detergent, antibiotic and/or perfume allergies
- Have been medically diagnosed as having a medical condition that precludes participation, such as: diabetes, hepatitis, an organ transplant, a medical surgical implant or an immune compromised system
- Have any medical condition which in the opinion of the Investigator prelude participation
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 |
|---|---|---|
| IV Clear™ DressingPolyurethane film, silicone adhesive dressing with chlorhexidine and silver | Device | IV Clear™ |
| Tegaderm CHG™Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate | Device | Tegaderm CHG™ |
| Silicone Vehicle Control DressingPolyurethane film with silicone adhesive dressing, without antimicrobials | Device | Vehicle Control Dressing |
Primary outcome
Change in skin microbial colonization over 7-day period of antimicrobial dressing application
Time frame: Assessed after 4 days and 7 days of dressing application
Mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline), following prepping with 70% isopropyl alcohol and following post treatment samplings of IV Clear™, Tegaderm™ CHG and Silicone control dressings collected.
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 16 Apr 2015.
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.
Dennis J Ward, D.O. principal investigator
Hill Top Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV Clear™ Dressing and Tegaderm CHG™ in people with Skin Flora Infection, run by Covalon Technologies Inc. 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 10 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 16 Apr 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. Some participants in this study may receive a placebo. 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 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.
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?
Change in skin microbial colonization over 7-day period of antimicrobial dressing application (time frame: Assessed after 4 days and 7 days of dressing application). 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 16 Apr 2015.