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Preoperative Bath in Patients Submitted to Hip Arthroplasty

Primary Purpose

Surgical Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
4% Chlorhexidine gluconate
10% PVPI degermante
Soap without antiseptic
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Preoperative Care, Baths, Chlorhexidine, Soaps, Povidone-Iodine, Arthroplasty, Replacement, Hip, Surgical Wound Infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Active Comparator

Arm Label

Bathing with 4% Chlorhexidine gluconate

Bathing with10% PVPI degermante

Bathing with soap without antiseptic.

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Infection of Surgical Site (SSI)
The infections that develop after the surgical procedure

Secondary Outcome Measures

Allergic reactions
Adverse reaction to a given product

Full Information

First Posted
December 20, 2016
Last Updated
February 26, 2019
Sponsor
Federal University of Minas Gerais
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT03001102
Brief Title
Preoperative Bath in Patients Submitted to Hip Arthroplasty
Official Title
Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Fundação de Amparo à Pesquisa do estado de Minas Gerais

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Preoperative Care, Baths, Chlorhexidine, Soaps, Povidone-Iodine, Arthroplasty, Replacement, Hip, Surgical Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bathing with 4% Chlorhexidine gluconate
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Bathing with10% PVPI degermante
Arm Type
Experimental
Arm Description
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.
Arm Title
Bathing with soap without antiseptic.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
4% Chlorhexidine gluconate
Other Intervention Name(s)
HiBiScrub, 4% Chlorhexidine degermante
Intervention Description
Cationic biguanide - antimicrobial action rubbing in the skin.
Intervention Type
Device
Intervention Name(s)
10% PVPI degermante
Other Intervention Name(s)
Betadine, 10% Povidone iodine degermante
Intervention Description
Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.
Intervention Type
Device
Intervention Name(s)
Soap without antiseptic
Other Intervention Name(s)
Non-medicated soap, Soap
Intervention Description
Liquid soap with glycerin, neutral pH. Skin cleansing
Primary Outcome Measure Information:
Title
Infection of Surgical Site (SSI)
Description
The infections that develop after the surgical procedure
Time Frame
During the first 90 days after surgery
Secondary Outcome Measure Information:
Title
Allergic reactions
Description
Adverse reaction to a given product
Time Frame
In the first hours after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lúcia MC Franco, PhD student
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Preoperative Bath in Patients Submitted to Hip Arthroplasty

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