Pilot Clinical Evaluation to Characterize the in Vivo Effects of Topically Applied ZuraPrep and ZuraPrep Vehicle

NCT02578771 Phase 3 COMPLETED

ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product and reference positive control will be compared; ZuraPrep non-active and negative control will be compared. Each subject will receive two of the planned treatments, one on the left side of body and one of the right. Study duration for subjects - 3 to 4 weeks.

Details

Lead sponsor	Zurex Pharma, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	123
Start date	2015-10
Completion	2016-01

Conditions

• Surgical Site Infection

Interventions

• ZuraPrep with 70% IPA
• ZuraPrep without 70% IPA
• ChloraPrep CHG/IPA Teal Tint
• Normal Saline

Primary outcomes

• Reduction of skin flora measured by Tentative Final Monograph (TFM) Proposed Amendment — 30 seconds
  calculated as log-10 CFU responder rates from baseline
• Reduction of skin flora measured by 1994 TFM — 10 minutes
  calculated as log-10 CFU reductions from baseline

Countries

United States