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

• Sponsor: Ricardo Becerro de Bengoa Vallejo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02500758
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Duration (Months): 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases; Surgical Site Infection	Procedure: Preparatory handwash; Procedure: Preoperative surgical scrubbing using 3% PCMX; Procedure: Preoperative surgical scrubbing using 4% CHG	N/A

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

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Preoperative Surgical Scrubbing in Reducing Bacterial Load, Using Chlorhexidine Digluconate (CHX) and Parachlorometaxylenol (PCMX)
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parachlorometaxylenol Reducing bacterial load after preoperative surgical scrubbing using 3% PCMX. Both hands have been prepared by preparatory handwash.	Procedure: Preparatory 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.; Procedure: Preoperative 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.; Other Names: Parachlorometaxylenol
Active Comparator: Clorhexidine digluconate Reducing bacterial load after preoperative surgical scrubbing using 4% CHG. Both hands have been prepared by preparatory handwash.	Procedure: Preparatory 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.; Procedure: Preoperative 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.; Other Names: Chlorexidine digluconate

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

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"). [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ricardo Becerro de Bengoa Vallejo

Investigators

• Principal Investigator: Ricardo Becerro de Bengoa Vallejo, DPM, Universidad Complutense de Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

• Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernández 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.

• Responsible Party: Ricardo Becerro de Bengoa Vallejo, Doctor of Podiatric Medicine, Universidad Complutense de Madrid
• ClinicalTrials.gov Identifier: NCT02500758
• Other Study ID Numbers: RBLM
• First Posted: Jul 16, 2015
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Ricardo Becerro de Bengoa Vallejo, Doctor of Podiatric Medicine, Universidad Complutense de Madrid: Surgical scrubbing; Chlorhexidine digluconate; Parachlorometaxylenol
• Additional relevant MeSH terms: Surgical Wound Infection; Skin Diseases; Chloroxylenol

Study Results

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 Detail	The volunteers are randomly divided into two groups of the same size, by tossing a coin.

Arm/Group Title	Parachlorometaxylenol Then Clorhexidine Digluconate	Chlorhexidine Digluconate Then Parachlorometaxylenol
Arm/Group Description	Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).	Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol). After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol.
Period Title: First Intervention (2 Minutes)
STARTED	15	15
COMPLETED	15	14
NOT COMPLETED	0	1
Period Title: First Intervention (2 Minutes)
STARTED	15	14
COMPLETED	13	12
NOT COMPLETED	2	2
Period Title: First Intervention (2 Minutes)
STARTED	13	12
COMPLETED	10	10
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Parachlorometaxylenol	Chlorhexidine Digluconate	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.02 (2.05)	24.62 (3.82)	24.83 (5.25)
Sex: Female, Male (Count of Participants)
Female	9 60%	12 80%	21 70%
Male	6 40%	3 20%	9 30%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parachlorometaxylenol	Chlorhexidine Digluconate
Arm/Group Description	Change in 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	Change in 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.
Measure Participants	20	20
Mean (95% Confidence Interval) [CFU/ml]	3.96	3.87

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parachlorometaxylenol	Chlorhexidine Digluconate
Arm/Group Description	Change in 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.	Change in 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.
Measure Participants	20	20
Mean (95% Confidence Interval) [CFU/ml]	4.54	4.65

Adverse Events

Time Frame	A week
Arm/Group Title	Parachlorometaxylenol		Chlorhexidine Digluconate
Arm/Group Description	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.		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.
All Cause Mortality
	Parachlorometaxylenol		Chlorhexidine Digluconate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Parachlorometaxylenol		Chlorhexidine Digluconate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Parachlorometaxylenol		Chlorhexidine Digluconate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.