SurgeryPhase 3NCT02222896
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects
A Phase 3 study testing Chlorhexidine Gluconate and DynaHex-2 in people with Surgery, run by Medline Industries at 1 site in United States.
Trial summary
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin. 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?
- Chlorhexidine Gluconate and DynaHex-2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to May 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
- Males or Females
- 16 years of age or older
- Signed informed consent
- Good Health
- Six inches of abdomen and groin areas without tattoos, or skin disorders
Who cannot join
- Dermatological Conditions
- Sensitivity to latex
- Sensitivity to CHG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.
Read the detailed description
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Also called CHG
2% CHG solution on cloth
VehicleOther
Also called Control
Excipients of CHG product only
DynaHex-2Drug
Also called CHG 2%
2% CHG solution
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Gluconate Cloth | Experimental | 2% CHG, single application Receives: Drug: Chlorhexidine Gluconate |
| Vehicle Cloth | Placebo comparator | Excipients on cloth Receives: Other: Vehicle |
| Active Chlorhexidine gluconate solution | Active comparator | Dynahex 2% CHG Receives: Drug: DynaHex-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin
Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline.
Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.
Measured: 10 minutes, 6 hours, 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionMay 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
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H Bashir, Principal investigator, MBT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222896
- Sponsor's protocol ID
- R13-053
- Status last verified
- Nov 2016
- First submitted
- 10 Aug 2014
- Last updated
- 21 May 2021
- 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 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
- ClinicalTrials.gov ID
- NCT02222896
- Acronym / sponsor ID
- R13-053
- Conditions
- Surgery
- Keywords
- Preoperative surgical skin preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.
Detailed description
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Gluconate Cloth | Experimental | Drug: Chlorhexidine Gluconate2% CHG, single application |
| Vehicle Cloth | Placebo comparator | Other: VehicleExcipients on cloth |
| Active Chlorhexidine gluconate solution | Active comparator | Drug: DynaHex-2Dynahex 2% CHG |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males or Females
- 16 years of age or older
- Signed informed consent
- Good Health
- Six inches of abdomen and groin areas without tattoos, or skin disorders
Key exclusion criteria (3 listed)
- Dermatological Conditions
- Sensitivity to latex
- Sensitivity to CHG
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 GluconateAlso: CHG2% CHG solution on cloth | Drug | Chlorhexidine Gluconate Cloth |
| VehicleAlso: ControlExcipients of CHG product only | Other | Vehicle Cloth |
| DynaHex-2Also: CHG 2%2% CHG solution | Drug | Active Chlorhexidine gluconate solution |
Primary outcome
Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin
Time frame: 10 minutes, 6 hours, 8 hours
Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline. Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- 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.
H Bashir principal investigator
MBT
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 Chlorhexidine Gluconate and DynaHex-2 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 5 inclusion and 3 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 21 May 2021. 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 21 May 2021). 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?
Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin (time frame: 10 minutes, 6 hours, 8 hours). 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 21 May 2021.