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

NCT03813693 | Completed DMC

• 1 other identifier: EEUSP
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Prevention of surgical site infection - Criteria: Centers for Disease Control and Prevention, 2018

  In order to investigate the potential cases of SSI, the researcher personally followed the patients in the preoperative period, in the POI and at the time of hospital discharge, using a data collection instrument. In order to evaluate the occurrence of SSI after hospital discharge, the researcher used the following strategies: a review of the chart associated with patient follow-up during outpatient return when possible, which would occur on average on the 35th postoperative day; telephone contact from the 30th day until the 40th postoperative day (PO), using a post-discharge surveillance instrument. Continuous and discrete quantitative variables were evaluated using the Wilcoxon-Mann-Whitney test. Qualitative (categorical) variables were evaluated using the Pearson X² test. The Wilcoxon-Mann-Whitney test was used for qualitative (categorical) variables, whose distribution was different from normal.

  1 month (30 days)

Study Arms (2)

towels with chlorhexidine gluconate 2%

EXPERIMENTAL

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.

Other: towels impregnated with 2% chlorhexidine gluconate

chlorhexidine gluconate 2% liquid

ACTIVE COMPARATOR

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.

Other: chlorhexidine gluconate 2% liquid

Interventions

towels impregnated with 2% chlorhexidine gluconate 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.

towels with chlorhexidine gluconate 2%

chlorhexidine gluconate 2% liquid 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.

chlorhexidine gluconate 2% liquid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Fernanda de Oliveira Andrade

Curitiba, Paraná, Brazil

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate; Fluid Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Fernanda Andrade

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Vanessa Poveda

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention group (GI) received two packs, each containing six towels impregnated with 2% chlorhexidine gluconate and an instruction manual on how to use them. Two bottles of chlorhexidine gluconate 2% liquid (100 ml) were given to the control group (CG), the patients were instructed to perform the bath using one vial the night before surgery and the other on the morning of surgery.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 23, 2019
• Study Start: May 2, 2017
• Primary Completion: August 28, 2018
• Study Completion: September 28, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)