Test for Pre Operative Skin Preparations

• Sponsor: CareFusion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00799812
• Collaborator: (none)
• Enrollment: 335
• Location: 1
• Arms: 5
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 46.6

Study Details

Study Description

Brief Summary

Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd 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 3

Detailed Description

Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized 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 evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 335 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)
• Actual Study Start Date: Nov 13, 2007
• Actual Primary Completion Date: Apr 27, 2008
• Actual Study Completion Date: Jun 19, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHG Swabstick (3 @ once) Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 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 Names: ChloraPrep Swabstick
Experimental: CHG Swabstick sequential Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially	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 Names: ChloraPrep Swabstick
Active Comparator: Hibiclens Chlorhexidine gluconate (CHG) 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 Names: Hibiclens
Placebo Comparator: Sterile water swab (3 @ once) Sterile swabstick wetted with sterile deionized 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 sequentially.	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.

Outcome Measures

Primary Outcome Measures

1. log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites [10 minutes and 6 hours after application of test solutions]

   The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects must read and sign an Informed Consent Form and be cooperative.

• Subjects must be in good general health.

• Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.

Exclusion Criteria:

• Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.

• A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.

• Any medical condition that in the opinion of the investigator would preclude participation.

• Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.

• Used UV tanning lamps 2 weeks prior to any microbial sampling.

• Bathing or showering less than 48 hours prior to any microbial sampling.

• Known sensitivity to chlorhexidine gluconate.

• Known sensitivity to latex (rubber).

• Known sensitivity to fragrances.

• Pregnant or nursing.

• Unwillingness to fulfill the performance requirements of the study.

• Subjects who have completed part or all of the study will not be reentered in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Microbiotest	Sterling	Virginia	United States	20164

Sponsors and Collaborators

• CareFusion

Investigators

• Principal Investigator: M. Hamid Bashir, MD, Medical Director

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 24, 2007

More Information

Publications

None provided.

• Responsible Party: CareFusion
• ClinicalTrials.gov Identifier: NCT00799812
• Other Study ID Numbers: ENT 371-121
• First Posted: Dec 1, 2008
• Last Update Posted: May 27, 2021
• Last Verified: May 1, 2021

• Keywords provided by CareFusion: antimicrobial; antisepsis
• Additional relevant MeSH terms: Chlorhexidine gluconate

Study Results

Participant Flow

Pre-assignment Detail	Each subject received more than one treatment. Randomization was done by testing site and each subject had 4 testing sites.

Arm/Group Title	All Study Participants
Arm/Group Description	Study Participants that were treated
Period Title: Overall Study
STARTED	335
CHG Swabstick (3 @ Once)	139
CHG Swabstick Sequential	138
Hibiclens	133
Sterile Water Swab (3 @ Once)	132
Sterile Water Swabstick (Sequential)	126
COMPLETED	335
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All Participants Who Completed Evaluations
Overall Participants	335
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.9 (14.1)
Sex: Female, Male (Count of Participants)
Female	149 44.5%
Male	186 55.5%
371-121 Preoperative Skin Preparations (Count of Participants)
CHG Swabstick (3 @ Once)	139 41.5%
CHG Swabstick (Sequential)	138 41.2%
Hibiclens	133 39.7%
Sterile Water Swab (3 @ Once)	132 39.4%
Sterile Water Swabstick (Sequential)	126 37.6%

Outcome Measures

1. Primary Outcome

Title	log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
Description	The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
Time Frame	10 minutes and 6 hours after application of test solutions

Outcome Measure Data

Analysis Population Description

Measure Analysis Population Description: Number analyzed is not equal to participants treated but rather equal to the number of treated sites for individuals who met the baseline bacterial load criteria on treatment day

Arm/Group Title	CHG Swabstick (3 @ Once)	CHG Swabstick Sequential	Hibiclens	Sterile Water Swab (3 @ Once)	Sterile Water Swabstick (Sequential)
Arm/Group Description	Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).: 3 swabsticks topically applied at the same time to intact skin	Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially 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.	Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base 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.	Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time. Sterile swabstick with sterile water (3 @ once): 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.	Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially. Sterile swabstick with sterile water (one-at-a-time): Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.
Measure Participants	111	112	111	111	112
Measure Number of Sites Analyzed	276	273	264	260	251
Groin site - 10 minutes	3.51 (0.62)	3.44 (0.64)	3.15 (0.53)	0.92 (0.47)	0.97 (0.55)
Groin site - 6 hours	3.22 (0.65)	3.24 (0.58)	2.89 (0.62)	0.82 (0.47)	0.85 (0.58)
Abdomen site - 10 minutes	2.56 (0.50)	2.58 (0.48)	2.76 (0.49)	0.54 (0.37)	0.50 (0.35)
Abdomen site - 6 hours	2.38 (0.60)	2.39 (0.64)	2.51 (0.66)	0.47 (0.38)	0.46 (0.39)

Adverse Events

Time Frame	During the study through the 6-hour time point evaluations
Arm/Group Title	CHG Swabstick (3 @ Once)		CHG Swabstick Sequential		Hibiclens		Sterile Water Swab (3 @ Once)		Sterile Water Swabstick (Sequential)
Arm/Group Description	Chlorhexidine gluconate (CHG) 2% CHG/isopropyl alcohol (IPA) 70%-3 swabsticks applied @ same time CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once): 3 swabsticks topically applied at the same time to intact skin		Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v--3 swabsticks applied sequentially CHG 2% w/v & IPA 70% v/v swabstick: 3 swabsticks applied sequentially to intact skin.		Chlorhexidine gluconate 4% w/v in an aqueous base Aqueous CHG 4% w/v applied according to manufacturer'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.		Sterile swabstick wetted with sterile deionized water--3 swabsticks applied at the same time. Sterile swabstick with sterile deionized water (3 @ once): 3 swabsticks wetted with sterile water topically applied to intact skin at the same time.		Sterile swabstick wetted with sterile deionized water--3 swabsticks applied sequentially. Sterile swabstick with sterile deionized water (sequentially): swabsticks wetted with sterile water topically applied to intact skin sequentially.
All Cause Mortality
	CHG Swabstick (3 @ Once)		CHG Swabstick Sequential		Hibiclens		Sterile Water Swab (3 @ Once)		Sterile Water Swabstick (Sequential)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/139 (0%)		0/138 (0%)		0/133 (0%)		0/132 (0%)		0/126 (0%)
Serious Adverse Events
	CHG Swabstick (3 @ Once)		CHG Swabstick Sequential		Hibiclens		Sterile Water Swab (3 @ Once)		Sterile Water Swabstick (Sequential)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/139 (0%)		0/138 (0%)		0/133 (0%)		0/132 (0%)		0/126 (0%)
Other (Not Including Serious) Adverse Events
	CHG Swabstick (3 @ Once)		CHG Swabstick Sequential		Hibiclens		Sterile Water Swab (3 @ Once)		Sterile Water Swabstick (Sequential)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/139 (0%)		0/138 (0%)		0/133 (0%)		0/132 (0%)		0/126 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.