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| Name | Class |
|---|---|
| Concejo de Ciencia y TecnologÃa del Estado de Guanajuato | UNKNOWN |
| Pisa SA de CV | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WHOLE GROUP OF 48 VOLUNTEERS | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period | Bacterial colony count of skin cultures to determine antiseptic properties | 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. | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Skin Reactions for the 10% Povidone-iodine Period | Presence of allergy or any skin reaction at 24 hours after the antiseptic application | 24 hours |
| Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro E Macias, M. D. | Universidad de Guanajuato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guanajuato School of Medicine | León | Guanajuato | 37000 | Mexico |
For stabilization of skin microbiota, all volunteers used neutral soap and shampoo without antiseptics over a period of two weeks, being advised to avoid swimming in pools.
Healthy volunteers recruited from August to December 2008 in the Microbiology Laboratory of University of Guanajuato, Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Whole Group | Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Povidone Iodine |
| |||||||||||||
| Sodium Hypochlorite |
| |||||||||||||
| Control |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Whole Group | Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period | Bacterial colony count of skin cultures to determine antiseptic properties | Posted | Median | Inter-Quartile Range | Colony-forming units per cm squared | 24 hours |
|
|
24 hours following the application of the antiseptics or control
All the participants were at risk for non-serious adverse events, "0" means that none suffered any adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Whole Group | Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Macias | University of Guanajuato | 52 477 7145859 | 400 | aaeemmhh@yahoo.com |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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|
|
Presence of allergy or skin reaction at 24 hours after the application of the antiseptic
| 24 hours |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Presence of Skin Reactions for the 10% Povidone-iodine Period | Presence of allergy or any skin reaction at 24 hours after the antiseptic application | A minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL, with a power of 80%, and bilateral error of 5%. Analysis per protocol. | Posted | Number | Number of participants with skin reactio | 24 hours |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Colony-forming units per cm squared | 24 hours |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Colony-forming units per cm squared | 24 hours |
|
|
|
| Secondary | 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 | Posted | Number | Number of participants with reaction | 24 hours |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
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| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.