Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

NCT02526667 | Completed Phase 3 Results

• 1 other identifier: R15-029
• Study Type: interventional
• Target: 340
• 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)

• Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin

  Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.

  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

DynaHex-2 DRUG

2% CHG solution

Also known as: CHG 2%

Active Chlorhexidine gluconate solution

Vehicle OTHER

Excipients of CHG product only

Also known as: Control

Vehicle Cloth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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)

Bio High Tech SRL

Bucharest, Romania

Location

MeSH Terms

Interventions

chlorhexidine gluconate

Results Point of Contact

• Title: Dr. Olsavszky
• Organization: Evic Romania

research@evic.ro

40 21 335 70 90

Study Officials

• R Olsavcszky, MD

  S.C. BIO HIGH TECH S.R.L.

  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 16, 2015
• First Posted: August 18, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 28, 2020
• Results First Posted: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

RO (1)