Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers

Surgery Clinical Trial

Official title:

Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526667
• Other study ID #: R15-029
• Status: Completed
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2020
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post Chlorhexidine Gluconate (CHG) application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or Females

• 18 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

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Chlorhexidine gluconate
2% CHG solution on cloth
• DynaHex-2
2% CHG solution

Other:
• Vehicle
Excipients of CHG product only

Locations

Country	Name	City	State
Romania	Bio High Tech SRL	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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