Back to resultsThe Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
towels impregnated with 2% chlorhexidine gluconate
chlorhexidine gluconate 2% liquid
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
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.
Sites / Locations
- Fernanda de Oliveira Andrade
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
towels with chlorhexidine gluconate 2%
chlorhexidine gluconate 2% liquid
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03813693
First Posted
January 9, 2019
Last Updated
January 20, 2019
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03813693
Brief Title
The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation
Official Title
Surgical Site Infection and the Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation: a Pilot Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
towels with chlorhexidine gluconate 2%
Arm Type
Experimental
Arm Description
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.
Arm Title
chlorhexidine gluconate 2% liquid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
towels impregnated with 2% chlorhexidine gluconate
Intervention Description
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
Intervention Name(s)
chlorhexidine gluconate 2% liquid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevention of surgical site infection - Criteria: Centers for Disease Control and Prevention, 2018
Description
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.
Time Frame
1 month (30 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Andrade
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa Poveda
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fernanda de Oliveira Andrade
City
Curitiba
State/Province
Parana
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation
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