Clinical trial NCT03813693: 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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Prevention of surgical site infection - Criteria: Centers for Disease Control and Prevention, 2018
timeFrame: 1 month (30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Fernanda de Oliveira Andrade
state: Parana
Study officials:
affiliation: University of Sao Paulo
name: Fernanda Andrade
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Vanessa Poveda
role: PRINCIPAL_INVESTIGATOR
References: