SurgeryPhase 1/2NCT02530554

Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation

A Phase 1/2 study testing CHG in people with Surgery, run by Medline Industries.

Completed

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

Trial summary

Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG 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?: CHG
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: No sites listed yet
Study dates: Jul 2015to Aug 2015
Phase: Phase 1/2
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

Healthy
No dermatological conditions

Who cannot join

Sensitivity to CHG
Sensitivity to natural latex rubber or adhesive skin products

About this study

Official title: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation

Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG

Read the detailed description

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.

Conditions: Surgery
Being tested: CHG
Keywords: Preoperative surgical skin preparation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHGDrug
Also called Chlorhexidine Gluconate
Single application

Study groups in NCT02530554
Study group	Role	What they receive
CHG Cloth	Experimental	3 min application time Receives: Drug: CHG
Comparator CHG	Active comparator	Marketed 2% CHG Receives: Drug: CHG

What is being measured

The primary outcome is the main question the study is designed to answer.

Log Change in Bacterial Flora on Abdomen and Groin
Change was calculated as the baseline time point minus the later time points over an 8 hour period.
Measured: 10 min, 6 hr and 8 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Aug 2015

First posted21 Aug 2015 (estimated)
Study startJul 2015
Primary completionAug 2015
Study completionAug 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02530554
Sponsor's protocol ID: R15-028
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

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?

Official record

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All Surgery trials

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: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation
ClinicalTrials.gov ID: NCT02530554
Acronym / sponsor ID: R15-028
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Medline IndustriesIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 21 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.

Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG

Detailed description

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CHG Cloth	Experimental	Drug: CHG3 min application time
Comparator CHG	Active comparator	Drug: CHGMarketed 2% CHG

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy
No dermatological conditions

Key exclusion criteria (2 listed)

Sensitivity to CHG
Sensitivity to natural latex rubber or adhesive skin products

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
CHGAlso: Chlorhexidine GluconateSingle application	Drug	CHG Cloth, Comparator CHG

Primary outcome

Log Change in Bacterial Flora on Abdomen and Groin
Time frame: 10 min, 6 hr and 8 hr
Change was calculated as the baseline time point minus the later time points over an 8 hour period.

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 3 Min Abdomen	12	12
CHG 3 Min Groin	14	14
Comparator CHG Abdomen	12	12
Comparator CHG Groin	14	14

Primary outcome: Log Change in Bacterial Flora on Abdomen and Groin

Time frame: 10 min, 6 hr and 8 hr. Mean (95% Confidence Interval). Unit: Log (CFU)

Measure	CHG 3 Min Abdomen n = 12	CHG 3 Min Groin n = 14	Comparator CHG Abdomen n = 12	Comparator CHG Groin n = 14
10 min	2.9 (2.1 to 3.7)	3.7 (3.0 to 4.4)	2.3 (1.5 to 3.1)	3.0 (2.3 to 3.7)
6 hour	2.9 (2.1 to 3.6)	3.9 (3.2 to 4.7)	2.5 (1.7 to 3.3)	3.3 (2.6 to 4.1)
8 hour	2.9 (2.2 to 3.6)	4.6 (3.9 to 5.3)	2.3 (1.5 to 3.0)	3.3 (2.7 to 4.0)

Adverse events

Time frame: Adverse events were monitored from baseline out to 8 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHG 3 Min and Comparator CHG	0 of 14 (0%)	0 of 14 (0%)	0 of 14

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.

Related trials for Surgery

Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma

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 Olsavszky, MD principal investigator

S.C. Bio High Tech S.R.L

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CHG in people with Surgery, run by Medline Industries.

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 2 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.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Log Change in Bacterial Flora on Abdomen and Groin (time frame: 10 min, 6 hr and 8 hr). 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 NCT02530554.

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.