Trial Outcomes & Findings for Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP) (NCT NCT02500758)

Last Updated: 2017-05-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

5 minutes

Results posted on

2017-05-31

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	Parachlorometaxylenol Then Clorhexidine Digluconate 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).	Chlorhexidine Digluconate Then 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.
First Intervention (2 Minutes) STARTED	15	15
First Intervention (2 Minutes) COMPLETED	15	14
First Intervention (2 Minutes) NOT COMPLETED	0	1
Washout (1 Week) STARTED	15	14
Washout (1 Week) COMPLETED	13	12
Washout (1 Week) NOT COMPLETED	2	2
Second Intervention (2 Minutes) STARTED	13	12
Second Intervention (2 Minutes) COMPLETED	10	10
Second Intervention (2 Minutes) NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Parachlorometaxylenol Then Clorhexidine Digluconate 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).	Chlorhexidine Digluconate Then 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.
First Intervention (2 Minutes) Withdrawal by Subject	0	1
Washout (1 Week) Lost to Follow-up	2	2
Second Intervention (2 Minutes) Withdrawal by Subject	2	0
Second Intervention (2 Minutes) Lost to Follow-up	0	1
Second Intervention (2 Minutes) Protocol Violation	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parachlorometaxylenol n=15 Participants 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.	Chlorhexidine Digluconate n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Continuous	25.02 years STANDARD_DEVIATION 2.05 • n=99 Participants	24.62 years STANDARD_DEVIATION 3.82 • n=107 Participants	24.83 years STANDARD_DEVIATION 5.25 • n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	12 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants

PRIMARY outcome

Timeframe: 5 minutes

Outcome measures

Outcome measures
Measure	Parachlorometaxylenol n=20 Participants 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	Chlorhexidine Digluconate n=20 Participants 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.
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 Interval 3.57 to 4.35	3.87 CFU/ml Interval 3.29 to 4.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Parachlorometaxylenol n=20 Participants 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	Chlorhexidine Digluconate n=20 Participants 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.
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 Interval 3.92 to 5.16	4.65 CFU/ml Interval 3.85 to 5.45

Adverse Events

Parachlorometaxylenol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorhexidine Digluconate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ricardo Becerro de Bengoa Vallejo

Universidad Complutense de Madrid

Phone: 914590409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place