Surgical Skin PreparationPhase 1NCT03331263
Single Dose CHG Pharmacokinetic Study
A Phase 1 study testing Chlorhexidine Gluconate in people with Surgical Skin Preparation, run by Medline Industries at 1 site in United States.
Trial summary
A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Skin Preparation
- What is being tested?
- Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 6 Aug 2017
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:
- non- or ex-smokers
- body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg
- negative pregnancy test for female subjects
- healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Algorithme Pharma USA LLC
Fargo, North Dakota, 58104
About this study
Official title: Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)
A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.
- Conditions
- Surgical Skin Preparation
- Being tested
- Chlorhexidine Gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
2% CHG
| Study group | Role | What they receive |
|---|---|---|
| Abdominal application of 2% CHG | Experimental | Not described Receives: Drug: Chlorhexidine Gluconate |
| Groin application of 2% CHG | Experimental | Not described Receives: Drug: Chlorhexidine Gluconate |
| Control treatment with no application | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.
A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.
Measured: Up to 24 hours after product application
Secondary outcomes (1)
Number of Subjects With of Treatment Emergent Adverse Events.
Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to 24 hours after product application, overall, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start21 Jul 2017
- Primary completion6 Aug 2017
- Study completion6 Aug 2017
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 Surgical Skin PreparationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Carlson, Pharm D., Principal investigator, Algorithme Pharma USA LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331263
- Sponsor's protocol ID
- R17-023
- Status last verified
- Apr 2021
- First submitted
- 23 Oct 2017
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Pharmacokinetic Study to Assess the Systemic Exposure of Chlorhexidine From ReadyPrep® CHG (2% Chlorhexidine Gluconate Cloth)
- ClinicalTrials.gov ID
- NCT03331263
- Acronym / sponsor ID
- R17-023
- Conditions
- Surgical Skin Preparation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 6 Aug 2017 (actual)
- Study completion
- 6 Aug 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abdominal application of 2% CHG | Experimental | Drug: Chlorhexidine Gluconate |
| Groin application of 2% CHG | Experimental | Drug: Chlorhexidine Gluconate |
| Control treatment with no application | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Chlorhexidine Gluconate2% CHG | Drug | Abdominal application of 2% CHG, Groin application of 2% CHG |
Primary outcome
Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.
Time frame: Up to 24 hours after product application
A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.
1 secondary outcome
Number of Subjects With of Treatment Emergent Adverse Events.
Time frame: Up to 24 hours after product application, overall, up to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
James Carlson, Pharm D. principal investigator
Algorithme Pharma USA LLC
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 Chlorhexidine Gluconate in people with Surgical Skin Preparation, 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 5 inclusion and 0 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 15 Dec 2023. 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 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?
Yes. Results are posted in the registry (first posted 15 Dec 2023). 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 Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. (time frame: Up to 24 hours after product 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 15 Dec 2023.