Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone | NCT00692757

Studies
Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone

NCT00692757

Sponsor

Universidad Tecnológica de Pereira

Status

Unknown status

Last Update Posted

Oct 21, 2008Estimated

Enrollment

432Estimated

Phase

Phase 2

Conditions

Surgical Site Infection

Interventions

Hypochlorous acid
Iodopovidone

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jan 2009Estimated

Completion Date

Mar 2009Estimated

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 5, 2008

First Posted Date

Jun 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2008

Last Update Posted Date

Oct 21, 2008Estimated

Name	Class
Hospital Universitario San Jorge de Pereira (HUSJ)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

432Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Hypochlorous acid	Drug: Hypochlorous acid
B	Active Comparator	Iodopovidone	Drug: Iodopovidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypochlorous acid	Drug	Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical site infection rates		until one month (weekly)

Secondary Outcomes

Measure	Description	Time Frame
Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site		one week

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juliana Buitrago, Master	Contact	313-649-0439		julianabuitrago@yahoo.com

Overall Officials

Name	Affiliation	Role
Juliana Buitrago, MD.,MSc	Universidad Tecnológica de Pereira	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario San Jorge (HUSJ)	Recruiting	Pereira	Risaralda Department		Colombia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16669304	Background	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.
17492051	Background	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.

ID	Term
D013530	Surgical Wound Infection
D003428	Cross Infection

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

ID	Term
D006997	Hypochlorous Acid
D011206	Povidone-Iodine

ID	Term
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D017606	Chlorine Compounds