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Completed

NCT Number: NCT03001102

Preoperative Bath in Patients Submitted to Hip Arthroplasty

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% Chlorhexidine gluconate

Device

Cationic biguanide - antimicrobial action rubbing in the skin.

Other names: HiBiScrub, 4% Chlorhexidine degermante

10% PVPI degermante

Device

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

Other names: Betadine, 10% Povidone iodine degermante

Soap without antiseptic

Device

Liquid soap with glycerin, neutral pH. Skin cleansing

Other names: Non-medicated soap, Soap

Primary outcomes

  1. Infection of Surgical Site (SSI)

    Time frame: During the first 90 days after surgery

    The infections that develop after the surgical procedure

Secondary outcomes

  1. Allergic reactions

    Time frame: In the first hours after procedure

    Adverse reaction to a given product

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2016
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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