Preoperative Bath in Patients Submitted to Hip Arthroplasty

Study Overview
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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.

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

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: 4% Chlorhexidine gluconate
* Device: 10% PVPI degermante
* Device: Soap without antiseptic


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Bathing with 4% Chlorhexidine gluconate<br>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<br>* Cationic biguanide - antimicrobial action rubbing in the skin.<br>* Other names: 4% Chlorhexidine degermante;|
| Experimental: Bathing with10% PVPI degermante<br>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<br>* Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.<br>* Other names: 10% Povidone iodine degermante;|
| Active Comparator: Bathing with soap without antiseptic.<br>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<br>* Liquid soap with glycerin, neutral pH. Skin cleansing<br>* Other names: Soap;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Care, Baths, Chlorhexidine, Soaps, Povidone-Iodine, Arthroplasty, Replacement, Hip, Surgical Wound Infection