SurgeryPhase 3NCT02526667

Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

A Phase 3 study testing Chlorhexidine gluconate and DynaHex-2 in people with Surgery, run by Medline Industries at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 18 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: 340 participants
Where: 1 siteRomania
Study dates: Aug 2015to Dec 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males or Females
18 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.

Romania1 site

Bio High Tech SRL
Bucharest

Other trials in Romania

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 Chlorhexidine Gluconate (CHG) application.

Conditions: Surgery
Being tested: Chlorhexidine gluconate, DynaHex-2, Vehicle
Keywords: Preoperative surgical skin preparation

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
DynaHex-2Drug
Also called CHG 2%
2% CHG solution
VehicleOther
Also called Control
Excipients of CHG product only

Study groups in NCT02526667
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.

Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.
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.

Aug 2015Dec 2015

First posted18 Aug 2015 (estimated)
Study startAug 2015
Primary completionDec 2015
Study completionDec 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: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02526667
Sponsor's protocol ID: R15-029
Status last verified: Sep 2020
First submitted: 16 Aug 2015
Last updated: 28 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Data to be shared with FDA.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2020. 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: NCT02526667
Acronym / sponsor ID: R15-029
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: Medline IndustriesIndustry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 18 Aug 2015 (estimated)
Results: Posted 28 Sep 2020

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 Chlorhexidine Gluconate (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: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or Females
18 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
DynaHex-2Also: CHG 2%2% CHG solution	Drug	Active Chlorhexidine gluconate solution
VehicleAlso: ControlExcipients of CHG product only	Other	Vehicle Cloth

Primary outcome

Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
Time frame: 10 minutes, 6 hours, 8 hours
Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.

Results and safety

Results posted to the registry on 28 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHG Cloth	284	284
Vehicle	56	56
Comparator CHG	281	281

Primary outcome: Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin

Time frame: 10 minutes, 6 hours, 8 hours. Number. Unit: Percent of sites

Measure	CHG 3 Min Abdomen n = 284	CHG 3 Min Groin n = 290	Vehicle Abdomen n = 56	Vehicle Groin n = 56	Comparator CHG Abdomen n = 281	Comparator CHG Groin n = 294
10 min	78	84	54	56	72	73
6 hours	100	100	96	100	99	100
8 hours	99	100	96	100	98	100

Population analysed: Number of participants involved in the analyses.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHG Cloth Abdomen	0 of 284 (0%)	0 of 284 (0%)	Not reported
Vehicle Abdomen	0 of 56 (0%)	0 of 56 (0%)	Not reported
Comparator CHG Abdomen	0 of 281 (0%)	0 of 281 (0%)	Not reported
CHG Cloth Groin	0 of 290 (0%)	0 of 290 (0%)	Not reported
Vehicle Groin	0 of 56 (0%)	0 of 56 (0%)	Not reported
Comparator CHG Groin	0 of 294 (0%)	0 of 294 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
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.

R Olsavcszky, MD principal investigator

S.C. BIO HIGH TECH S.R.L.

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 Romania.

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 28 Sep 2020. 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 Romania. 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 28 Sep 2020). 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?

Responder Rates (%) of Sites Identified for 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?

On the ClinicalTrials.gov record for NCT02526667.

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 28 Sep 2020.