Preoperative Bath in Patients Submitted to Hip Arthroplasty

Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial

Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Device: 4% Chlorhexidine gluconate; Device: 10% PVPI degermante; Device: Soap without antiseptic

Detailed Description

Despite the recommendation in several guidelines of preoperative bathing with 4% chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the literature that support this practice. The objective of this study is to evaluate the effect of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10% povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients undergoing elective hip arthroplasty surgery. The specific objectives are to compare the incidence of SSI in the three interventions, to assess the most effective intervention for the prevention of surgical infection and to estimate the frequency of allergic reactions caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip arthroplasty in each group will be randomized to perform the baths in the period from may 2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to investigate colonization by Staphylococcus aureus.

The expected result is lower ISC rate with the proposed measures.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Federal University of Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be 18 or older;
• Elective procedure of total hip arthroplasty
• No report of infectious focus at the surgical site
• Know to respond to the clinical signs of a surgical infection or having a person responsible with this ability
• Do not be a nasal carrier of Staphylococcus aureus before surgery
• Have access to fixed or mobile phone

Exclusion Criteria:

• Patient treating surgical site infection
• Emergency hip prosthesis surgery or orthopedic trauma
• Nasal carriers of Staphylococcus aureus before surgery
• Previous history of allergic reactions to the products used in the bat

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Bathing with 4% Chlorhexidine gluconate; Two baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery.	Device: 4% Chlorhexidine gluconate; Cationic biguanide - antimicrobial action rubbing in the skin.; Other Names: HiBiScrub; 4% Chlorhexidine degermante
EXPERIMENTAL: Bathing with10% PVPI degermante; Two baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.	Device: 10% PVPI degermante; Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.; Other Names: Betadine; 10% Povidone iodine degermante
ACTIVE_COMPARATOR: Bathing with soap without antiseptic.; Two baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.	Device: Soap without antiseptic; Liquid soap with glycerin, neutral pH. Skin cleansing; Other Names: Non-medicated soap; Soap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection of Surgical Site (SSI)	The infections that develop after the surgical procedure	During the first 90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allergic reactions	Adverse reaction to a given product	In the first hours after procedure

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Fundação de Amparo à Pesquisa do estado de Minas Gerais
• Investigators: Principal Investigator: Lúcia MC Franco, PhD student, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (ESTIMATE): December 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Povidone-Iodine; Preoperative Care; Chlorhexidine; Arthroplasty, Replacement, Hip; Surgical Wound Infection; Baths; Soaps
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone-Iodine; Povidone; Chlorhexidine gluconate; Anti-Infective Agents, Local
• Other Study ID Numbers: EE-UFMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.