Surgical Site InfectionPhase 2WASHNCT00692757
Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone
A Phase 2 study testing Hypochlorous acid and Iodopovidone in people with Surgical Site Infection, run by Universidad Tecnológica de Pereira at 1 site in Colombia.
Trial summary
The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Hypochlorous acid and Iodopovidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients requiring mesh or prosthesis or orthesis
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario San Jorge (HUSJ)
Pereira, Risaralda Department
Rodolfo A Cabrales, MD., 57-6-333-0014, rocabster@gmail.com
German A Moreno, MD.,MSc, 57-6-333-7126, gamo@cable.net.co
About this study
Official title: Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection
The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- Hypochlorous acid, Iodopovidone
- Keywords
- Hypochlorous Acid, Colony forming units, surgical site infection, nosocomial infection, bacterial bioburden, wound healing
- Medical subject headings
- Surgical Wound Infection, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous acidDrug
Also called NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA
Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray
IodopovidoneDrug
Iodopovidone
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Hypochlorous acid Receives: Drug: Hypochlorous acid |
| B | Active comparator | Iodopovidone Receives: Drug: Iodopovidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection rates
Measured: until one month (weekly)
Secondary outcomes (1)
Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Tecnológica de Pereira
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Jorge de Pereira (HUSJ)
- Investigators
- Juliana Buitrago, MD.,MSc, Principal investigator, Universidad Tecnológica de Pereira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692757
- Sponsor's protocol ID
- 5-07-9
- Acronym
- WASH
- Status last verified
- Oct 2008
- First submitted
- 3 Jun 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16669304Robson 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.
PubMed 17492051Wang 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.
PubMed 17492050
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection
- ClinicalTrials.gov ID
- NCT00692757
- Acronym / sponsor ID
- WASH / 5-07-9
- Conditions
- Surgical Site Infection
- Keywords
- Hypochlorous Acid, Colony forming units, surgical site infection, nosocomial infection, bacterial bioburden, wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Universidad Tecnológica de PereiraUniversity, hospital or other
- Collaborators
- Hospital Universitario San Jorge de Pereira (HUSJ)
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Hypochlorous acidHypochlorous acid |
| B | Active comparator | Drug: IodopovidoneIodopovidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients requiring mesh or prosthesis or orthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypochlorous acidAlso: NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CAHypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray | Drug | A |
| IodopovidoneIodopovidone | Drug | B |
Primary outcome
Surgical site infection rates
Time frame: until one month (weekly)
1 secondary outcome
Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
- Background: PubMed 16669304Selkon 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.
- Background: PubMed 17492051Robson 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.
- Background: PubMed 17492050Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana Buitrago, MD.,MSc principal investigator
Universidad Tecnológica de Pereira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypochlorous acid and Iodopovidone in people with Surgical Site Infection, run by Universidad Tecnológica de Pereira at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Buitrago, Master (313-649-0439, julianabuitrago@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection rates (time frame: until one month (weekly)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692757, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.