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

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Other: towels impregnated with 2% chlorhexidine gluconate; Other: chlorhexidine gluconate 2% liquid

• Registration Number: NCT03813693
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2017-05-02
• Primary Completion: 2018-08-28
• Study Completion: 2018-09-28
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-20
• Last Update Submitted: 2019-01-20
• Study First Posted: 2019-01-23
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
towels with chlorhexidine gluconate 2%	towels impregnated with 2% chlorhexidine gluconate	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.
chlorhexidine gluconate 2% liquid	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.

Primary Outcome Measures

Name	Time	Method
Prevention of surgical site infection - Criteria: Centers for Disease Control and Prevention, 2018	1 month (30 days)	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.

Trial Locations

Locations (1)

Fernanda de Oliveira Andrade; 🇧🇷 Curitiba, Parana, Brazil