Clinical trial NCT03001102: Preoperative Bath in Patients Submitted to Hip Arthroplasty
Official title: Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Preoperative Care
Baths
Chlorhexidine
Soaps
Povidone-Iodine
Arthroplasty, Replacement, Hip
Surgical Wound Infection
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2016-12-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Infection of Surgical Site (SSI)
timeFrame: During the first 90 days after surgery
Secondary outcomes:
measure: Allergic reactions
timeFrame: In the first hours after procedure
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Lúcia MC Franco, PhD student
role: PRINCIPAL_INVESTIGATOR
References: