Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects

NCT02222896 | Completed Phase 3 Results

• 1 other identifier: R13-053
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Conditions

Surgery

Keywords

Preoperative surgical skin preparation

Outcome Measures

Primary Outcomes (1)

• Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin

  Percent of abdomen and groin sites that showed response (achieve a 2-Log and 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.

  10 minutes, 6 hours, 8 hours

Study Arms (3)

Chlorhexidine Gluconate Cloth

EXPERIMENTAL

2% CHG, single application

Drug: Chlorhexidine Gluconate

Vehicle Cloth

PLACEBO COMPARATOR

Excipients on cloth

Other: Vehicle

Active Chlorhexidine gluconate solution

ACTIVE COMPARATOR

Dynahex 2% CHG

Drug: DynaHex-2

Interventions

Chlorhexidine Gluconate DRUG

2% CHG solution on cloth

Also known as: CHG

Chlorhexidine Gluconate Cloth

Vehicle OTHER

Excipients of CHG product only

Also known as: Control

Vehicle Cloth

DynaHex-2 DRUG

2% CHG solution

Also known as: CHG 2%

Active Chlorhexidine gluconate solution

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or Females
• years of age or older
• Signed informed consent
• Good Health
• Six inches of abdomen and groin areas without tattoos, or skin disorders

You may not qualify if:

• Dermatological Conditions
• Sensitivity to latex
• Sensitivity to CHG

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

MBT

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate

Results Point of Contact

• Title: Dr. Bashir
• Organization: Microbac

muhammad.bashir@microbac.com

703-925-9366

Study Officials

• H Bashir

  MBT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 21, 2021
• Results First Posted: May 21, 2021

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)