Healthy Volunteers
Conditions
Keywords
Antiseptics, Administration, cutaneous, Iodophors, Chlorine compounds, Anti-infecting agents, local
Brief 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. 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.
Interventions
OTHERWHOLE GROUP OF 48 VOLUNTEERS
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.
Sponsors
Concejo de Ciencia y Tecnología del Estado de Guanajuato
Pisa SA de CV
Universidad de Guanajuato
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult volunteers.
Exclusion criteria
* History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period | 24 hours | Bacterial colony count of skin cultures to determine antiseptic properties |
| Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period | 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 | 24 hours | After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Skin Reactions for the 10% Povidone-iodine Period | 24 hours | Presence of allergy or any skin reaction at 24 hours after the antiseptic application |
| Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period | 24 hours | Presence of allergy or skin reaction at 24 hours after the application of the antiseptic |
Countries
Mexico
Participant flow
Recruitment details
Healthy volunteers recruited from August to December 2008 in the Microbiology Laboratory of University of Guanajuato, Mexico.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Whole Group Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Whole Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age Continuous | 24.4 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment Mexico | 48 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Whole Group | Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period | 192 Colony-forming units per cm squared |
Comparison: The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.p-value: <0.05Kruskal-Wallis
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.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Whole Group | Bacterial Colony Forming Units for the Control Period | 1500 Colony-forming units per cm squared |
Primary
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
Bacterial colony count of skin cultures to determine antiseptic properties
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Whole Group | Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period | 231 Colony-forming units per cm squared |
Comparison: The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.p-value: <0.05Kruskal-Wallis
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
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Whole Group | Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period | 0 Number of participants with reaction |
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
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Whole Group | Presence of Skin Reactions for the 10% Povidone-iodine Period | 0 Number of participants with skin reactio |