Healthy VolunteersPhase 3NCT00738543
Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics
A Phase 3 study testing WHOLE GROUP OF 48 VOLUNTEERS in people with Healthy Volunteers, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study is needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- WHOLE GROUP OF 48 VOLUNTEERS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2008to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers.
Who cannot join
- History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex
Trial locations and contacts
1 site in 1 country.
Mexico1 site
University of Guanajuato School of Medicine
León, Guanajuato, 37000
About this study
Official title: Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.
The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study is needed. The investigators want to know if there are difference between the use of 10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.
Read the detailed description
Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit site of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. To have more options, this study is needed to know if 10% sodium hypochlorite is similar to the most common option for skin antisepsis.
- Conditions
- Healthy Volunteers
- Being tested
- WHOLE GROUP OF 48 VOLUNTEERS
- Keywords
- Antiseptics, Administration, cutaneous, Iodophors, Chlorine compounds, Anti-infecting agents, local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOLE GROUP OF 48 VOLUNTEERSOther
Also called Isodine (R), Exsept (R)
Two antiseptics (10% povidone iodine and 10% sodium hypochlorite) and one control were tested as skin antiseptics. The intervention consisted of preparing the skin with the antiseptic or the control. The areas were approximately 25 cm2 on the forearm for each antiseptic or control. The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution. The solution was then kept on the skin for 60 seconds before the bacterial culture was conducted. All volunteers were instructed to continue the use of neutral soap and shampoo without antiseptics during the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Whole group of 48 volunteers | Experimental | The arm is composed of 48 human volunteers to test 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City), Hypochlorite 10% of electrochemical production (Exsept 10% ®, Pisa, Guadalajara, Mexico), and control. Receives: Other: WHOLE GROUP OF 48 VOLUNTEERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
Bacterial colony count of skin cultures to determine antiseptic properties
Measured: 24 hours
Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Measured: 24 hours
Bacterial Colony Forming Units for the Control Period
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Measured: 24 hours
Secondary outcomes (2)
Presence of Skin Reactions for the 10% Povidone-iodine Period
Presence of allergy or any skin reaction at 24 hours after the antiseptic application
Measured: 24 hours
Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period
Presence of allergy or skin reaction at 24 hours after the application of the antiseptic
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Collaborators
- Concejo de Ciencia y Tecnología del Estado de Guanajuato, Pisa SA de CV
- Responsible party
- Principal investigator, Alejandro E. Macias, Universidad de Guanajuato
- Investigators
- Alejandro E Macias, M. D., Principal investigator, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738543
- Sponsor's protocol ID
- FMUGAmuch
- Status last verified
- Feb 2009
- First submitted
- 18 Aug 2008
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.
- ClinicalTrials.gov ID
- NCT00738543
- Acronym / sponsor ID
- FMUGAmuch
- Conditions
- Healthy Volunteers
- Keywords
- Antiseptics, Administration, cutaneous, Iodophors, Chlorine compounds, Anti-infecting agents, local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Collaborators
- Concejo de Ciencia y Tecnología del Estado de Guanajuato, Pisa SA de CV
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Posted 17 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study is needed. The investigators want to know if there are difference between the use of 10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.
Detailed description
Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit site of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. To have more options, this study is needed to know if 10% sodium hypochlorite is similar to the most common option for skin antisepsis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole group of 48 volunteers | Experimental | Other: WHOLE GROUP OF 48 VOLUNTEERSThe arm is composed of 48 human volunteers to test 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City), Hypochlorite 10% of electrochemical production (Exsept 10% ®, Pisa, Guadalajara, Mexico), and control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult volunteers.
Key exclusion criteria (1 listed)
- History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex
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 |
|---|---|---|
| WHOLE GROUP OF 48 VOLUNTEERSAlso: Isodine (R), Exsept (R)Two antiseptics (10% povidone iodine and 10% sodium hypochlorite) and one control were tested as skin antiseptics. The intervention consisted of preparing the skin with the antiseptic or the control. The areas were approximately 25 cm2 on the forearm for each antiseptic or control. The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution. The solution was then kept on the skin for 60 seconds before the bacterial culture was conducted. All volunteers were instructed to continue the use of neutral soap and shampoo without antiseptics during the follow-up period. | Other | Whole group of 48 volunteers |
Primary outcome
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
Time frame: 24 hours
Bacterial colony count of skin cultures to determine antiseptic properties
Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period
Time frame: 24 hours
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Bacterial Colony Forming Units for the Control Period
Time frame: 24 hours
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
2 secondary outcomes
Presence of Skin Reactions for the 10% Povidone-iodine Period
Time frame: 24 hours
Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alejandro E Macias, M. D. principal investigator
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WHOLE GROUP OF 48 VOLUNTEERS in people with Healthy Volunteers, run by Universidad de Guanajuato at 1 site in Mexico.
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 1 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: finished, as of the sponsor's last update on 24 Jun 2013. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2013.