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Test for Preoperative Skin Preparations

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ClinicalTrials.gov Identifier: NCT00799812
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
CareFusion

Brief Summary:
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile water) applied using the same method as the ChloraPrep Swabstick.

Condition or disease Intervention/treatment Phase
Topical Antisepsis Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially Drug: Aqueous CHG 4% w/v applied according to mfr's directions Other: Sterile swabstick with sterile water (3 @ once) Other: Sterile swabstick with sterile water (one-at-a-time) Phase 1 Phase 2

Detailed Description:

Determine differences (if any)in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used one-at-a-time. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile water) applied as a negative comparison using the same method as the ChloraPrep swabstick.

Study uses topical sampling from the abdomen and the groin on intact skin and evaluate the germs left on the skin after treatment with ChloraPrep Swabsticks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)
Study Start Date : November 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008


Arm Intervention/treatment
Experimental: CHG Swabstick (3 @ once)
Chlorhexidine(CHG)2% CHG/isopropyl alcohol (IPA)70%-3 swabsticks applied @ same time
Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).
3 swabsticks topically applied at the same time to intact skin
Other Name: ChloraPrep Swabstick

Experimental: CHG Swabstick sequential
Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v--3 swabsticks applied one-at-a-time
Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially
Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.
Other Name: ChloraPrep Swabstick

Active Comparator: Hibiclens
Chlorhexidine gluconate 4% w/v in an aqueous base
Drug: Aqueous CHG 4% w/v applied according to mfr's directions
Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.
Other Name: Hibiclens

Placebo Comparator: Sterile water swab (3 @ once)
Sterile swabstick wetted with sterile water--3 swabsticks applied at the same time.
Other: Sterile swabstick with sterile water (3 @ once)
3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.

Placebo Comparator: Sterile water swabstick (sequential)
Sterile swabstick wetted with sterile water--3 swabsticks applied one-at-a-time.
Other: Sterile swabstick with sterile water (one-at-a-time)
Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.




Primary Outcome Measures :
  1. Determine differences in log reductions in CFU/cm2 on inguinal and abdominal sites when using 2 different application techniques [ Time Frame: 10 minutes and 6 hours after application of test solutions ]


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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
Criteria

Inclusion Criteria:

  • Free of dermatoses, cuts, lesions, or other skin disorders on or around test sites;
  • No exposures to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for 14 day pre-test conditioning period and must agree to abstain from these materials until completion of study.

Exclusion Criteria:

  • Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos,or medicated lotions;
  • Use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14 day pre-test conditioning period or during the test period;
  • Exposure of test sites to strong detergent, solvents, or other irritants during the 14 day pre-test conditioning period or during the test period;
  • Use of systemic or topical antibiotic medications, steroid medication other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the 14 day pre-test conditioning period or during the test period.
  • Known allergies to vinyl, latex (rubber), alcohols, metals, inks or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol;
  • A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures;
  • Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child;
  • Any currently active skin disease or inflammatory skin condition including contact dermatitis; Showering or bathing within the 72 hour period prior to sampling; Participation in another clinical study in the past 30 days or current participation in another clinical study; Any medical condition or use of any medication, that, in the opinion of the Study Director, should preclude participation;
  • Unwillingness to fulfill the performance requirements of the study.

Information from the National Library of Medicine

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): NCT00799812


Locations
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United States, Virginia
Microbiotest
Sterling, Virginia, United States, 20164
Sponsors and Collaborators
CareFusion
Investigators
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Principal Investigator: M.Hamid Bashir, MD Medical Director
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Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT00799812    
Other Study ID Numbers: ENT 371-121
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Keywords provided by CareFusion:
antimicrobial
antisepsis
Additional relevant MeSH terms:
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Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents