Skin DiseasesECPNCT02500758
Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP)
A study testing Preparatory handwash, Preoperative surgical scrubbing using 3% PCMX and Preoperative surgical scrubbing using 4% CHG in people with Skin Diseases and Surgical Site Infection, run by Ricardo Becerro de Bengoa Vallejo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Surgical Site Infection
- What is being tested?
- Preparatory handwash, Preoperative surgical scrubbing using 3% PCMX and Preoperative surgical scrubbing using 4% CHG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2016
- Phase
- Interventional
- 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
- 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).
Who cannot join
- History of eczema.
- History of psoriasis.
- Allergies to any of the ingredients of the solutions or contraindication to its use.
About this study
Official title: Effectiveness of Preoperative Surgical Scrubbing in Reducing Bacterial Load, Using Chlorhexidine Digluconate (CHX) and Parachlorometaxylenol (PCMX)
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.
Read the 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.
- Conditions
- Skin Diseases, Surgical Site Infection
- Being tested
- Preparatory handwash, Preoperative surgical scrubbing using 3% PCMX, Preoperative surgical scrubbing using 4% CHG
- Keywords
- Surgical scrubbing, Chlorhexidine digluconate, Parachlorometaxylenol
- Medical subject headings
- Skin Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparatory handwashProcedure or surgery
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.
Preoperative surgical scrubbing using 3% PCMXProcedure or surgery
Also called Parachlorometaxylenol
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.
Preoperative surgical scrubbing using 4% CHGProcedure or surgery
Also called Chlorexidine digluconate
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.
| Study group | Role | What they receive |
|---|---|---|
| Parachlorometaxylenol | Experimental | Reducing bacterial load after preoperative surgical scrubbing using 3% PCMX. Both hands have been prepared by preparatory handwash. Receives: Procedure: Preparatory handwash; Procedure: Preoperative surgical scrubbing using 3% PCMX |
| Clorhexidine digluconate | Active comparator | Reducing bacterial load after preoperative surgical scrubbing using 4% CHG. Both hands have been prepared by preparatory handwash. Receives: Procedure: Preparatory handwash; Procedure: Preoperative surgical scrubbing using 4% CHG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (1)
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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJan 2016
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin DiseasesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo Becerro de Bengoa Vallejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid
- Investigators
- Ricardo Becerro de Bengoa Vallejo, DPM, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500758
- Sponsor's protocol ID
- RBLM
- Acronym
- ECP
- Status last verified
- May 2017
- First submitted
- 20 Jun 2015
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernandez DS, Prieto JP. Efficacy of intraoperative surgical irrigation with polihexanide and nitrofurazone in reducing bacterial load after nail removal surgery. J Am Acad Dermatol. 2011 Feb;64(2):328-35. doi: 10.1016/j.jaad.2010.01.011. Epub 2010 Nov 26.
PubMed 21112671Vallejo RBB, Fernandez DS, Cervera LA, Aragon LM, Iglesias MEL, Yurrita LRC, Lopez DL. Effectiveness of surgical hand antisepsis using chlorhexidine digluconate and parachlorometaxylenol hand scrub: Cross-over trial. Medicine (Baltimore). 2018 Oct;97(42):e12831. doi: 10.1097/MD.0000000000012831.
PubMed 30334981
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preoperative Surgical Scrubbing in Reducing Bacterial Load, Using Chlorhexidine Digluconate (CHX) and Parachlorometaxylenol (PCMX)
- ClinicalTrials.gov ID
- NCT02500758
- Acronym / sponsor ID
- ECP / RBLM
- Conditions
- Skin Diseases, Surgical Site Infection
- Keywords
- Surgical scrubbing, Chlorhexidine digluconate, Parachlorometaxylenol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ricardo Becerro de Bengoa VallejoUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 21 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parachlorometaxylenol | Experimental | Procedure: Preparatory handwash, Procedure: Preoperative surgical scrubbing using 3% PCMXReducing bacterial load after preoperative surgical scrubbing using 3% PCMX. Both hands have been prepared by preparatory handwash. |
| Clorhexidine digluconate | Active comparator | Procedure: Preparatory handwash, Procedure: Preoperative surgical scrubbing using 4% CHGReducing bacterial load after preoperative surgical scrubbing using 4% CHG. Both hands have been prepared by preparatory handwash. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- History of eczema.
- History of psoriasis.
- Allergies to any of the ingredients of the solutions or contraindication to its use.
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 |
|---|---|---|
| Preparatory handwashPreparatory 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. | Procedure or surgery | Clorhexidine digluconate, Parachlorometaxylenol |
| Preoperative surgical scrubbing using 3% PCMXAlso: ParachlorometaxylenolBoth 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. | Procedure or surgery | Parachlorometaxylenol |
| Preoperative surgical scrubbing using 4% CHGAlso: Chlorexidine digluconateBoth 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. | Procedure or surgery | Clorhexidine digluconate |
Primary outcome
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").
Time frame: 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.
1 secondary outcome
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").
Time frame: 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21112671Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernandez DS, Prieto JP. Efficacy of intraoperative surgical irrigation with polihexanide and nitrofurazone in reducing bacterial load after nail removal surgery. J Am Acad Dermatol. 2011 Feb;64(2):328-35. doi: 10.1016/j.jaad.2010.01.011. Epub 2010 Nov 26.
- Derived from this study: PubMed 30334981Vallejo RBB, Fernandez DS, Cervera LA, Aragon LM, Iglesias MEL, Yurrita LRC, Lopez DL. Effectiveness of surgical hand antisepsis using chlorhexidine digluconate and parachlorometaxylenol hand scrub: Cross-over trial. Medicine (Baltimore). 2018 Oct;97(42):e12831. doi: 10.1097/MD.0000000000012831.
- Individual participant dataSharing planned: Undecided
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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.
Ricardo Becerro de Bengoa Vallejo, DPM principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Preparatory handwash, Preoperative surgical scrubbing using 3% PCMX and Preoperative surgical scrubbing using 4% CHG in people with Skin Diseases and Surgical Site Infection, run by Ricardo Becerro de Bengoa Vallejo.
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 4 inclusion and 3 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2017). 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?
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"). (time frame: 5 minutes). 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 NCT02500758, which also lists 2 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 31 May 2017.