HealthyPhase 4NCT01290978
Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin
A Phase 4 study testing ChloraPrep and DuraPrep in people with Healthy, run by Solventum US LLC at 1 site in United States.
Trial summary
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ChloraPrep and DuraPrep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2010
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is willing to sign the Research Consent form
- Healthy male or female subjects ages between 18 - 65
- Subject has agreed to be and appears to be compliant with requirements of the study
- Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples
- Subject is willing to have the back clipped or shaved if it has excessive hair
Who cannot join
- Sensitivity/allergy to adhesive products (e.g. medical tapes)
- Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG)
- Allergy to seafood
- History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials
- Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back
- History of diabetes
Show all 11Show fewer
- Subject is currently pregnant or thinks she may be pregnant or is nursing
- Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy
- Subject is taking antihistamine medication
- Subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study
- Subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
cyberDERM Clinical Studies
Broomall, Pennsylvania, 19008
About this study
Official title: Prospective, Randomized Comparison of Two Presurgical Skin Antiseptic Preparations and Resultant Surgical Incise Drape Adhesion to Skin
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
Read the detailed description
Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.
- Conditions
- Healthy
- Being tested
- ChloraPrep, DuraPrep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraPrepDrug
Also called ChloraPrep® with Tint (Scrub Teal®)
The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule
DuraPrepDrug
Also called 3M™ DuraPrep™ Surgical Solution
The application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule
| Study group | Role | What they receive |
|---|---|---|
| ChloraPrep | Active comparator | Applied ChloraPrep on the application site per manufacturer's instruction Receives: Drug: ChloraPrep |
| DuraPrep | Active comparator | Apply DuraPrep to the application site per manufacturer's instruction Receives: Drug: DuraPrep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drape Adhesion
The peel force to remove the sample
Measured: 30 minutes
Secondary outcomes (1)
Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively
Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
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 HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cyberderm Inc., 3M
- Responsible party
- Sponsor
- Investigators
- Gary L Grove, PhD, Principal investigator, Cyberderm Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290978
- Sponsor's protocol ID
- 05-011219
- Status last verified
- Sep 2024
- First submitted
- 4 Feb 2011
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparison of Two Presurgical Skin Antiseptic Preparations and Resultant Surgical Incise Drape Adhesion to Skin
- ClinicalTrials.gov ID
- NCT01290978
- Acronym / sponsor ID
- 05-011219
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- Cyberderm Inc., 3M
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 5 Mar 2013
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 find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
Detailed description
Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChloraPrep | Active comparator | Drug: ChloraPrepApplied ChloraPrep on the application site per manufacturer's instruction |
| DuraPrep | Active comparator | Drug: DuraPrepApply DuraPrep to the application site per manufacturer's instruction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is willing to sign the Research Consent form
- Healthy male or female subjects ages between 18 - 65
- Subject has agreed to be and appears to be compliant with requirements of the study
- Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples
- Subject is willing to have the back clipped or shaved if it has excessive hair
Key exclusion criteria (11 listed)
- Sensitivity/allergy to adhesive products (e.g. medical tapes)
- Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG)
- Allergy to seafood
- History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials
- Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back
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 |
|---|---|---|
| ChloraPrepAlso: ChloraPrep® with Tint (Scrub Teal®)The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule | Drug | ChloraPrep |
| DuraPrepAlso: 3M™ DuraPrep™ Surgical SolutionThe application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule | Drug | DuraPrep |
Primary outcome
Drape Adhesion
Time frame: 30 minutes
The peel force to remove the sample
1 secondary outcome
Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- 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.
Gary L Grove, PhD principal investigator
Cyberderm Inc.
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 ChloraPrep and DuraPrep in people with Healthy, run by Solventum US LLC 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 5 inclusion and 11 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 2 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2013). 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?
Drape Adhesion (time frame: 30 minutes). 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 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.