Skin Diseases, Surgical Site Infection
Conditions
Keywords
Surgical scrubbing, Chlorhexidine digluconate, Parachlorometaxylenol
Brief summary
Despite the wide variety of products and antiseptic agents, no agent is ideal for every situation. The investigators would like to evaluate the difference in reducing bacterial load, using 4% chlorhexidine digluconate and 3% parachlorometaxylenol after a preoperative surgical scrubbing.
Detailed description
The investigators conducted a controlled, prospective, randomized study to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using 4% chlorhexidine digluconate and 3% parachlorometaxylenol. Samples were taken from the hands of each volunteer after a preparatory handwash, pre-surgical scrubbing, post-surgical scrubbing and 3 hours after surgical scrubbing.
Interventions
PROCEDUREPreparatory handwash
Preparatory handwash follows the UNE-EN 12791 standard using a diluted soft soap, 200g/1000g, made in community pharmacy service and sterilize in autoclave. Washing hands were prepared without use of a brush for 1 minute with 10 ml of soft soap. After being rinsed with running tap water, they are thoroughly dried with paper towels.
PROCEDUREPreoperative surgical scrubbing using 3% PCMX
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
PROCEDUREPreoperative surgical scrubbing using 4% CHG
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Sponsors
Ricardo Becerro de Bengoa Vallejo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* No systemic diseases. * Healthy skin on hands, without cuts or abrasions. * Short and clean fingernails. * No use of substances with antimicrobial action (e.g. medicated soaps or creams).
Exclusion criteria
* History of eczema. * History of psoriasis. * Allergies to any of the ingredients of the solutions or contraindication to its use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- Baseline and 5 Minutes). | 5 minutes | Number of colony-forming units (CFU) sampled up to 5 minutes after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate. After surgical scrubbing and drying, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- Baseline and 3 Hours). | 3 hours | Number of colony-forming units (CFU) sampled 3 hours after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate, using surgical gloves. After surgical scrubbing, drying and wearing surgical gloves, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA. |
Participant flow
Recruitment details
The recruitment process started in june 2015 and ended in august 2015, involving 20 healthy adult volunteers, who were recruited in Nursing, Physiotherapy and Podiatry School of Complutense University of Madrid.
Pre-assignment details
The volunteers are randomly divided into two groups of the same size, by tossing a coin.
Participants by arm
| Arm | Count |
|---|---|
| Parachlorometaxylenol Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard. | 15 |
| Chlorhexidine Digluconate Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.
Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
Preparatory handwash follows the UNE-EN 12791 standard. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (2 Minutes) | Withdrawal by Subject | 0 | 1 |
| Second Intervention (2 Minutes) | Lost to Follow-up | 0 | 1 |
| Second Intervention (2 Minutes) | Protocol Violation | 1 | 1 |
| Second Intervention (2 Minutes) | Withdrawal by Subject | 2 | 0 |
| Washout (1 Week) | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Parachlorometaxylenol | Chlorhexidine Digluconate | Total |
|---|---|---|---|
| Age, Continuous | 25.02 years STANDARD_DEVIATION 2.05 | 24.62 years STANDARD_DEVIATION 3.82 | 24.83 years STANDARD_DEVIATION 5.25 |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- Baseline and 5 Minutes).
Number of colony-forming units (CFU) sampled up to 5 minutes after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate. After surgical scrubbing and drying, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Parachlorometaxylenol | Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- Baseline and 5 Minutes). | 3.96 CFU/ml |
| Chlorhexidine Digluconate | Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- Baseline and 5 Minutes). | 3.87 CFU/ml |
Secondary
Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- Baseline and 3 Hours).
Number of colony-forming units (CFU) sampled 3 hours after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate, using surgical gloves. After surgical scrubbing, drying and wearing surgical gloves, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.
Time frame: 3 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Parachlorometaxylenol | Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- Baseline and 3 Hours). | 4.54 CFU/ml |
| Chlorhexidine Digluconate | Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- Baseline and 3 Hours). | 4.65 CFU/ml |