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Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP) (ECP)

Primary Purpose

Skin Diseases, Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preparatory handwash
Preoperative surgical scrubbing using 3% PCMX
Preoperative surgical scrubbing using 4% CHG
Sponsored by
Ricardo Becerro de Bengoa Vallejo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Diseases focused on measuring Surgical scrubbing, Chlorhexidine digluconate, Parachlorometaxylenol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Parachlorometaxylenol

    Clorhexidine digluconate

    Arm Description

    Reducing bacterial load after preoperative surgical scrubbing using 3% PCMX. Both hands have been prepared by preparatory handwash.

    Reducing bacterial load after preoperative surgical scrubbing using 4% CHG. Both hands have been prepared by preparatory handwash.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 20, 2015
    Last Updated
    May 2, 2017
    Sponsor
    Ricardo Becerro de Bengoa Vallejo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02500758
    Brief Title
    Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP)
    Acronym
    ECP
    Official Title
    Effectiveness of Preoperative Surgical Scrubbing in Reducing Bacterial Load, Using Chlorhexidine Digluconate (CHX) and Parachlorometaxylenol (PCMX)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ricardo Becerro de Bengoa Vallejo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Diseases, Surgical Site Infection
    Keywords
    Surgical scrubbing, Chlorhexidine digluconate, Parachlorometaxylenol

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Parachlorometaxylenol
    Arm Type
    Experimental
    Arm Description
    Reducing bacterial load after preoperative surgical scrubbing using 3% PCMX. Both hands have been prepared by preparatory handwash.
    Arm Title
    Clorhexidine digluconate
    Arm Type
    Active Comparator
    Arm Description
    Reducing bacterial load after preoperative surgical scrubbing using 4% CHG. Both hands have been prepared by preparatory handwash.
    Intervention Type
    Procedure
    Intervention Name(s)
    Preparatory handwash
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Preoperative surgical scrubbing using 3% PCMX
    Other Intervention Name(s)
    Parachlorometaxylenol
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Preoperative surgical scrubbing using 4% CHG
    Other Intervention Name(s)
    Chlorexidine digluconate
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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").
    Description
    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
    Secondary Outcome Measure Information:
    Title
    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").
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ricardo Becerro de Bengoa Vallejo, DPM
    Organizational Affiliation
    Universidad Complutense de Madrid
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21112671
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30334981
    Citation
    Vallejo 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.
    Results Reference
    derived

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    Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP)

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