NCT03140254

A RANDOMIZED, SINGLE-CENTER, BLINDED, PILOT CLINICAL EVALUATION OF THE ANTIMICROBIAL EFFECTIVENESS OF THERMALLY TREATED CLOTHS IMPREGNATED WITH 0.4% OCTENIDINE DIHYDROCHLORIDE AQUEOUS SOLUTION COMPARED TO THERMALLY TREATED CLOTHS IMPREGNATED WITH VEHICLE FORMULATION AND TO SAGE 2% CHLORHEXIDINE GLUCONATE CLOTH FOR PREOPERATIVE SKIN PREPARATION

Completed Phase 2 Results posted Last updated 25 November 2025

What this trial tests

Phase 2 trial testing Chlorhexidine gluconate in Preoperative Skin Preparation in 145 participants. Completed in 17 March 2017.

Timeline

1 September 2016

Primary endpoint
17 March 2017

17 March 2017

Quick facts

Lead sponsor	C. R. Bard
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	145
Start date	1 September 2016
Primary completion	17 March 2017
Estimated completion	17 March 2017
Sites	1 location across United States

Drugs / interventions tested

• Chlorhexidine gluconate — full drug profile →
• N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride — full drug profile →
• Placebo

Conditions studied

• Preoperative Skin Preparation — all drugs for Preoperative Skin Preparation →

Sponsor

C. R. Bard — full company profile →

Who can join

18 and older, any sex, with Preoperative Skin Preparation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Abdominal Site Responder Rates at 10 Minutes
  Time frame: 10 min
  Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm\^2 CFU reduction were considered "responders," and individually treated groin sites wi
• Percentage of Abdominal Site Responder Rates at 6 Hours
  Time frame: 6 hours
  Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
• Percentage of Groin Site Responder Rate at 6 Hours
  Time frame: 6 hours
  Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
• Percentage of Groin Sites Responder Rates at 10 Minutes
  Time frame: 10 minutes
  Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered "responders."

Sponsor's own description

The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.