Preoperative CHG Cloth (2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02291601 |
Recruitment Status :
Completed
First Posted : November 14, 2014
Last Update Posted : December 8, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Surgical Skin Preparation | Drug: Chlorhexidine Gluconate Other: Vehicle Drug: 2% Chlorhexidine Gluconate Solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 879 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation |
Study Start Date : | October 2014 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Chlorhexidine Gluconate Cloth
2% CHG, single application
|
Drug: Chlorhexidine Gluconate
comparison with other CHG products |
Placebo Comparator: Vehicle Cloth
Excipients on cloth
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Other: Vehicle
Cloth with Excipients no CHG |
Active Comparator: Active Chlorhexidine gluconate solution
Dynahex 2% CHG
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Drug: 2% Chlorhexidine Gluconate Solution
CHG solution
Other Name: DynaHex |
- Count the number of bacteria on skin [ Time Frame: 10 minutes to 8 hours ]Bacteria on the skin will be evaluated at time 0, 10 minutes, 6 hours and 8 hours after treatment.
- Assess the side effects on the skin [ Time Frame: 10 min to 8 hours ]Treated skin will be assessed for any irritation.

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Dermatological Conditions
- Sensitivity to latex
- Sensitivity to CHG

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291601
United States, Montana | |
BioScience | |
Butte, Montana, United States, 59701 |
Principal Investigator: | C Beausoleil | BS |
Responsible Party: | Medline Industries |
ClinicalTrials.gov Identifier: | NCT02291601 |
Other Study ID Numbers: |
R13-052 |
First Posted: | November 14, 2014 Key Record Dates |
Last Update Posted: | December 8, 2015 |
Last Verified: | December 2015 |
Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local |
Anti-Infective Agents Disinfectants Dermatologic Agents |