The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation

NCT ID: NCT03813693

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2018-09-28

Brief Summary

To compare the use of towels impregnated with 2% chlorhexidine gluconate in the traditional preoperative bath with 2% chlorhexidine gluconate in preventing the occurrence of surgical site infection among patients undergoing potentially contaminated elective surgery.

Detailed Description

This is a pilot randomized controlled clinical trial, composed of patients submitted to potentially contaminated elective surgeries, randomly assigned to an intervention group, consisting of those who used towels impregnated with pre-operative CHG 2% and control group, composed of by the pre-operative bath with 2% conventional / liquid CHG. Both used the products the night before and the morning of surgery and received verbal and written guidance.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

towels with chlorhexidine gluconate 2%

Composed of 25 patients, who received 2 towels with chlorhexidine gluconate 2% packages each containing six towels and detailed instructions on the form and sequence of application of the towels; the time of application, that is, the night before surgery, between 20 and 22h, and, on the morning of surgery, between 5 and 6h; besides other general orientations.

Group Type: EXPERIMENTAL

towels impregnated with 2% chlorhexidine gluconate

Intervention Type: OTHER

The first TICHG should be used on the neck, chest and abdomen; The second TICHG should be used on the right upper limb, start at the shoulder; The third TICHG was intended for the upper left limb; The fourth TICHG should be used on the neck and chest; The fifth TICHG was for the right lower limb; The sixth TICHG should be used on the lower left limb.

2) Time of application: use six TICHGs the night before surgery and the six remaining on the morning of surgery.

3) After the hygiene of each member, discard the TICHG. After use of TICHG, allow the product to dry on the skin. Do not use bath towels to dry yourself and wear clean clothes.

chlorhexidine gluconate 2% liquid

Composed of 23 patients, two 100 ml flasks of chlorhexidine gluconate 2% liquid were supplied, and detailed instruction manual for the product, containing form and application sequence; time of application (the night before surgery, between 20 and 22h, and on the morning of surgery, between 5 and 6h); and general guidelines.

Group Type: ACTIVE_COMPARATOR

chlorhexidine gluconate 2% liquid

Intervention Type: OTHER

Spread the product on the skin during the bath and massage for 3 minutes, so that it is distributed equally to all parts of the body (except the face, hair and intimate area). Then rinse with water and dry with a clean, dry towel, and wear clean clothes.

Interventions

towels impregnated with 2% chlorhexidine gluconate

The first TICHG should be used on the neck, chest and abdomen; The second TICHG should be used on the right upper limb, start at the shoulder; The third TICHG was intended for the upper left limb; The fourth TICHG should be used on the neck and chest; The fifth TICHG was for the right lower limb; The sixth TICHG should be used on the lower left limb.

2) Time of application: use six TICHGs the night before surgery and the six remaining on the morning of surgery.

3) After the hygiene of each member, discard the TICHG. After use of TICHG, allow the product to dry on the skin. Do not use bath towels to dry yourself and wear clean clothes.

Intervention Type: OTHER

chlorhexidine gluconate 2% liquid

Spread the product on the skin during the bath and massage for 3 minutes, so that it is distributed equally to all parts of the body (except the face, hair and intimate area). Then rinse with water and dry with a clean, dry towel, and wear clean clothes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years of age or over
• literate
• undergoing potentially contaminated elective surgeries
• admitted on the day before the surgical treatment or in the triple three-day hospital stay prior to surgery, without an infectious or otherwise infected process
• correctly follow the instructions for the use of towels impregnated with chlorhexidine gluconate 2%
• follow the instructions for the use of chlorhexidine gluconate 2%

Exclusion Criteria

• submitted to previous surgeries, in a period of less than thirty days, or ninety days in the case of a prosthesis implant
• present skin lesions or known allergy to chlorhexidine gluconate 2%
• patients submitted to videolaparoscopic surgeries and vaginal surgeries
• patients who had daily use of products containing antiseptics (creams and / or liquid or bar soaps containing CHG, triclosan or similar) in their daily activity; or who had used antibiotics or similar drugs two weeks before and during the period of data collection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fernanda de Oliveira Andrade

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernanda Andrade

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Vanessa Poveda

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Fernanda de Oliveira Andrade

Curitiba, Paraná, Brazil

Countries

Brazil

Other Identifiers

EEUSP

Identifier Type: -

Identifier Source: org_study_id