Preoperative CHG Cloth on Healthy Subjects

NCT02291601 | Completed Phase 3 Results

• 1 other identifier: R13-052
• Study Type: interventional
• Target: 879
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the effects of 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 Sites

  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.

  10 minutes to 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

comparison with other CHG products

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% Solution

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)

BioScience

Butte, Montana, 59701, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate; Chromogranins; Solutions

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Pharmaceutical Preparations

Results Point of Contact

• Title: C Beausoleil
• Organization: Bioscience Labs

cbeausoleil@biosciencelabs.com

460-782-5498

Study Officials

• C Beausoleil

  BS

  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: November 11, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 30, 2021
• Results First Posted: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)