SurgeryPhase 3NCT02224625
Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth
A Phase 3 study testing 2% CHG Cloth solution, Active Comparator and Saline in people with Surgery, run by Medline Industries at 1 site in United States.
Trial summary
Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- 2% CHG Cloth solution, Active Comparator and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jun 2015
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Free of skin disorders
- Signed consent
Who cannot join
- Allergies to latex
- Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
- severe illness
- Pregnant (females)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product
Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.
Read the detailed description
For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.
The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.
- Conditions
- Surgery
- Being tested
- 2% CHG Cloth solution, Vehicle Cloth, Active Comparator, Saline, SLS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% CHG Cloth solutionDrug
Also called Chlorhexidine Gluconate
Investigational CHG
Vehicle ClothDevice
Also called Control
Excipients from CHG cloth only
Active ComparatorDrug
Also called DynaHex-2
Active comparator
SalineOther
Negative control
SLSOther
Also called Sodium Lauryl Sulfate
Provides a slight irritation for a positive control
| Study group | Role | What they receive |
|---|---|---|
| 2% CHG Cloth | Experimental | Chlorhexidine Gluconate 2% Receives: Drug: 2% CHG Cloth solution |
| Vehicle Cloth | Placebo comparator | Excipients on cloth Receives: Device: Vehicle Cloth |
| DynaHex (2% CHG) | Active comparator | Chlorhexidine Gluconate 2% solution Receives: Drug: Active Comparator |
| Saline | Sham comparator | 0.9% sodium chloride Receives: Other: Saline |
| Sodium Lauryl Sulfate (SLS) | Active comparator | Sodium lauryl sulfate to produce mild irritation as a positive control Receives: Other: SLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading Scale for Visual Evaluation of Skin Condition
Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.
Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.
Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading
Measured: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
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 SurgeryStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J Pullman, MD, Principal investigator, BioScience Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224625
- Sponsor's protocol ID
- R13-051
- Status last verified
- Mar 2016
- First submitted
- 20 Aug 2014
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data to be shared with FDA
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product
- ClinicalTrials.gov ID
- NCT02224625
- Acronym / sponsor ID
- R13-051
- Conditions
- Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.
Detailed description
For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.
The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2% CHG Cloth | Experimental | Drug: 2% CHG Cloth solutionChlorhexidine Gluconate 2% |
| Vehicle Cloth | Placebo comparator | Device: Vehicle ClothExcipients on cloth |
| DynaHex (2% CHG) | Active comparator | Drug: Active ComparatorChlorhexidine Gluconate 2% solution |
| Saline | Sham comparator | Other: Saline0.9% sodium chloride |
| Sodium Lauryl Sulfate (SLS) | Active comparator | Other: SLSSodium lauryl sulfate to produce mild irritation as a positive control |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Free of skin disorders
- Signed consent
Key exclusion criteria (4 listed)
- Allergies to latex
- Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
- severe illness
- Pregnant (females)
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 |
|---|---|---|
| 2% CHG Cloth solutionAlso: Chlorhexidine GluconateInvestigational CHG | Drug | 2% CHG Cloth |
| Vehicle ClothAlso: ControlExcipients from CHG cloth only | Device | Vehicle Cloth |
| Active ComparatorAlso: DynaHex-2Active comparator | Drug | DynaHex (2% CHG) |
| SalineNegative control | Other | Saline |
| SLSAlso: Sodium Lauryl SulfateProvides a slight irritation for a positive control | Other | Sodium Lauryl Sulfate (SLS) |
Primary outcome
Grading Scale for Visual Evaluation of Skin Condition
Time frame: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)
Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested. Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data to be shared with FDA
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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.
J Pullman, MD principal investigator
BioScience Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% CHG Cloth solution, Active Comparator and Saline in people with Surgery, run by Medline Industries 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 2 inclusion and 4 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 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 30 May 2016). 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?
Grading Scale for Visual Evaluation of Skin Condition (time frame: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)). 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 2017.