NCT00692757

Brief Summary

The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
432

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

6 months

First QC Date

June 3, 2008

Last Update Submit

October 20, 2008

Conditions

Surgical Site Infection

Keywords

Hypochlorous AcidColony forming unitssurgical site infectionnosocomial infectionbacterial bioburdenwound healing

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection rates

    until one month (weekly)

Secondary Outcomes (1)

  • Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site

    one week

Study Arms (2)

A

EXPERIMENTAL

Hypochlorous acid

Drug: Hypochlorous acid

B

ACTIVE COMPARATOR

Iodopovidone

Drug: Iodopovidone

Interventions

Hypochlorous acidDRUG

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

Also known as: NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA
A
IodopovidoneDRUG

Iodopovidone

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients requiring mesh or prosthesis or orthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario San Jorge (HUSJ)

Pereira, Risaralda Department, Colombia

RECRUITING

Related Publications (3)

  • Selkon JB, Cherry GW, Wilson JM, Hughes MA. Evaluation of hypochlorous acid washes in the treatment of chronic venous leg ulcers. J Wound Care. 2006 Jan;15(1):33-7. doi: 10.12968/jowc.2006.15.1.26861.

    PMID: 16669304BACKGROUND

  • Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr 11;6:e6.

    PMID: 17492051BACKGROUND

  • Wang L, Bassiri M, Najafi R, Najafi K, Yang J, Khosrovi B, Hwong W, Barati E, Belisle B, Celeri C, Robson MC. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr 11;6:e5.

    PMID: 17492050BACKGROUND

MeSH Terms

Conditions

Surgical Wound InfectionCross Infection

Interventions

Hypochlorous AcidPovidone-Iodine

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsIatrogenic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Acids, NoncarboxylicAcidsInorganic ChemicalsChlorine CompoundsReactive Oxygen SpeciesFree RadicalsOxidesOxygen CompoundsIodophorsIodine CompoundsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Juliana Buitrago, MD.,MSc

    Universidad Tecnológica de Pereira

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Buitrago, Master

CONTACT

313-649-0439julianabuitrago@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 6, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

CO(1)