Trial | NCT00692757  Report issue

Title

Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone
Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    432
The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.
A topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. A stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans.

To assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area.
Study Started
Jul 31
2008
Primary Completion
Jan 31
2009
Anticipated
Study Completion
Mar 31
2009
Anticipated
Last Update
Oct 21
2008
Estimate

Drug Hypochlorous acid

Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray

  • Other names: NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA

Drug Iodopovidone

Iodopovidone

A Experimental

Hypochlorous acid

B Active Comparator

Iodopovidone

Criteria 

Inclusion Criteria:

All patients over 18 years old, who are going to be operated
Classification of surgical wounds according to the National Research Council as class I or II
Risk index classification of the American Society of Anaesthesiology (ASA) as ASA 1 or 2

Exclusion Criteria:

Patients requiring mesh or prosthesis or orthesis
No Results Posted