Preoperative CHG Cloth on Healthy Subjects

• ClinicalTrials.gov Identifier: NCT02291601
• Recruitment Status: Completed
• First Posted: November 14, 2014
• Results First Posted: April 30, 2021
• Last Update Posted: April 30, 2021
• Sponsor: Medline Industries
• Information provided by (Responsible Party): Medline Industries

Tracking Information

• First Submitted Date: November 11, 2014
• First Posted Date: November 14, 2014
• Results First Submitted Date: February 3, 2016
• Results First Posted Date: April 30, 2021
• Last Update Posted Date: April 30, 2021
• Study Start Date: October 2014
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 29, 2021)

Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites [ Time Frame: 10 minutes to 8 hours ]

Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline. Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline.

Original Primary Outcome Measures (submitted: November 13, 2014)

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.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: November 13, 2014)

Assess the side effects on the skin [ Time Frame: 10 min to 8 hours ]

Treated skin will be assessed for any irritation.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Preoperative CHG Cloth on Healthy Subjects
• Official Title: Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
• Brief Summary: Evaluate the effects of 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 area post CHG application.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Surgery

Intervention

• Drug: Chlorhexidine Gluconate
  comparison with other CHG products
  Other Name: CHG
• Other: Vehicle
  Excipients of CHG product only.
  Other Name: Control
• Drug: DynaHex-2
  2% CHG solution
  Other Name: CHG 2% Solution

Study Arms

• Experimental: Chlorhexidine Gluconate Cloth
  2% CHG, single application
  Intervention: Drug: Chlorhexidine Gluconate
• Placebo Comparator: Vehicle Cloth
  Excipients on cloth
  Intervention: Other: Vehicle
• Active Comparator: Active Chlorhexidine gluconate solution
  Dynahex 2% CHG
  Intervention: Drug: DynaHex-2

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 5, 2015): 879
• Original Estimated Enrollment (submitted: November 13, 2014): 375
• Actual Study Completion Date: September 2015
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02291601
• Other Study ID Numbers: R13-052
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data to be shared with FDA

• Responsible Party: Medline Industries
• Study Sponsor: Medline Industries
• Collaborators: Not Provided

Investigators

• Principal Investigator: C Beausoleil; BS

• PRS Account: Medline Industries
• Verification Date: April 2021