Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone

NCT ID: NCT00692757

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Surgical Site Infection

Keywords

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Hypochlorous Acid Colony forming units surgical site infection nosocomial infection bacterial bioburden wound healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Hypochlorous acid

Group Type EXPERIMENTAL

Hypochlorous acid

Intervention Type DRUG

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

B

Iodopovidone

Group Type ACTIVE_COMPARATOR

Iodopovidone

Intervention Type DRUG

Iodopovidone

Interventions

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Hypochlorous acid

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

Intervention Type DRUG

Iodopovidone

Iodopovidone

Intervention Type DRUG

Other Intervention Names

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NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario San Jorge de Pereira (HUSJ)

UNKNOWN

Sponsor Role collaborator

Universidad Tecnológica de Pereira

OTHER

Sponsor Role lead

Responsible Party

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Universidad Tecnológica de Pereira

Principal Investigators

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Juliana Buitrago, MD.,MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad Tecnológica de Pereira

Locations

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Hospital Universitario San Jorge (HUSJ)

Pereira, Risaralda Department, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Juliana Buitrago, Master

Role: CONTACT

Phone: 313-649-0439

Email: [email protected]

Facility Contacts

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Rodolfo A Cabrales, MD.

Role: primary

German A Moreno, MD.,MSc

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 16669304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17492051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17492050 (View on PubMed)

Other Identifiers

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5-07-9

Identifier Type: -

Identifier Source: org_study_id