Preoperative Bath in Patients Submitted to Hip Arthroplasty

NCT ID: NCT03001102

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type SHAM_COMPARATOR

4% Chlorhexidine gluconate

Intervention Type DEVICE

Cationic biguanide - antimicrobial action rubbing in the skin.

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.

Group Type EXPERIMENTAL

10% PVPI degermante

Intervention Type DEVICE

Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.

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.

Group Type ACTIVE_COMPARATOR

Soap without antiseptic

Intervention Type DEVICE

Liquid soap with glycerin, neutral pH. Skin cleansing

Interventions

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4% Chlorhexidine gluconate

Cationic biguanide - antimicrobial action rubbing in the skin.

Intervention Type DEVICE

10% PVPI degermante

Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.

Intervention Type DEVICE

Soap without antiseptic

Liquid soap with glycerin, neutral pH. Skin cleansing

Intervention Type DEVICE

Other Intervention Names

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HiBiScrub 4% Chlorhexidine degermante Betadine 10% Povidone iodine degermante Non-medicated soap Soap

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Lucia Maciel de Castro Franco

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lúcia MC Franco, PhD student

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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EE-UFMG

Identifier Type: -

Identifier Source: org_study_id

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